Orthopaedic Device Recall Dashboard - Orthopaedic Surgery Patient Safety

The Device Recall Dashboard (the “Dashboard”) was developed by the AAOS Committee on Devices, Biologics, and Technology and the Patient Safety Committee (the “Committee”) to assist the AAOS membership in identifying Class 1 and Class 2 device recalls relevant to their orthopaedic practice. The status of the recalls are based on member volunteer stakeholders interpretation of publicly available information from the U.S. Food and Drug Administration (FDA).

The recalls of these devices on the Device Recall Dashboard reflect the Committees interpretation of the publicly available device database, and do not imply liability of safety, effectiveness, or approval of use by AAOS. Clinicians should use their own, independent medical judgment, in addition to open discussion with the patient, when developing patient care recommendations and device selection.

While the Committee intends to update the Dashboard quarterly, AAOS makes no representations or warranties that the Dashboard contains all relevant device information and/or the most up-to-date status information. Clinicians are encouraged to independently confirm whether a Class 1 or 2 device has been subject to a recall. Use of the Dashboard is subject to applicable AAOS policies, including by not limited to the AAOS Privacy Policy and Terms of Use.

Orthopaedics makes up the single largest specialty of medical devices and accounts for approximately 20 percent of all recalls issued by the FDA. It is critical that orthopaedic surgeons understand their role in improving patient safety through device surveillance.

The goal of the Device Recall Dashboard is to provide orthopaedic surgeons with timely recall information that will ensure the quality of patient care and protect the health and well-being of their patients.

Recall Event ID	Manufacturer Name	Product Name	Specialty	Recall Date	FDA Device Number	Recall Class	Manufacturer Reason
90118	Smith & Nephew, Inc.	TRIGEN INTERTAN	Trauma	5/25/22	K040212	2	Under Investigation
89868	American Contract Systems	Orthopedic Tray	Arthroscopy	5/6/22		2	Process control
89959	DePuy	VELYS™ Robotic-Assisted Solution	Arthroplasty; Spine	5/2/22	K202769	2	Software design
89983	restor3d Inc.	Non-Sterile Double Ended Trial Kit	Spine	4/29/22		2	Process change control
89764	Nextremity Solutions	FLEXFUSION (TM) FIXATION IMPLANT	Foot and Ankle	4/12/22	K110445	2	Nonconforming Material/Component
89672	Stradis Medical	Anterior Hip Pack - Surgical Kit	Arthroplasty	4/4/22		2	Process change control
89671	Stradis Medical	Total Knee Pack - Surgical Kit	Arthroplasty	4/4/22		2	Process change control
89507	Wright Medical Technology	ORTHOLOC 2.0/2.4 PLATE SYSTEM	Foot and Ankle	3/15/22	K090692	2	Process Control
89619	Zimmer	NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE	Arthroplasty	3/3/22	K110054	2	Under Investigation by firm
89471	ROi CPS	Regard, TOTAL HIP - SPRINGFIELD	Arthroplasty	2/28/22		2	Under Investigation by firm
89544	Biomet	Arcos Modular Revision Hip System	Shoulder and Elbow	2/24/22		2	Process Control
89428	Synthes	Universal Chuck	Arthroplasty	2/10/22		2	Device Design
89454	DePuy	ATTUNE Revision Knee System	Arthroplasty	2/9/22	K160700	2	Nonconforming Material/Component
89471	ROi CPS	Regard, TOTAL HIP - SPRINGFIELD	Arthroplasty	2/28/22		2	Under Investigation by firm
89428	Synthes	Universal Chuck	Arthroplasty	2/10/22		2	Device Design
89454	DePuy	ATTUNE Revision Knee System	Arthroplasty	2/9/22	K160700	2	Nonconforming Material/Component
89177	Ellipse Technologies	ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	Spine	1/26/22	K140178	2	Device Design
89240	DePuy	DEPUY GLOBAL UNITE SHOULDER SYSTEM GLOBAL UNITE Platform Shoulder System	Shoulder and Elbow	1/11/22	K101996; K170748	2	Equipment Maintenance
89092	Conventus Orthopaedics	Flex-ThreadTM Distal Fibula Intramedullary Nail System	Arthroplasty	1/3/22	K202858	2	Device Design
92286	Smith & Nephew, Inc.	ENGAGE Cementless Partial Knee System	Arthroplasty	5/31/23	K190439	2	Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
92257	Stryker Orthopaedics	Triathlon Total Knee System	Arthroplasty	5/30/23	K173849	2	Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
92088	Linkbio Corp.	LINK SLED Knee System:	Arthroplasty	5/4/23	K954186	2	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
92078	Wright Medical Technology, Inc.	stryker ORTHOLOC 3Di Fusion Plate MTP	Foot and Ankle	4/26/23	K120359	2	Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
91973	SPINEART SA	Juliet® Ti LL Lumbar Interbody Device	Spine	4/24/23	K190877	2	JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay.
91947	Medacta Usa Inc	MectaLIF Anterior Extension	Spine	4/19/23	K221545	2	There is a potential for breakage of the small screw used to affix the anti-backout plate.
91974	Smith & Nephew, Inc.	JOURNEY II UNI XLPE TIBIA INSERT	Arthroplasty	4/14/23	K190085	2	A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
91906	Encore Medical, LP	EMPOWR Porous Patella	Arthroplasty	4/12/23	K212941	2	Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.
91913	MAKO SURGICAL CORPORATION	MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM; RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM	Arthroplasty	4/12/23	K082172; K090763	2	Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
91869	Limacorporate S.p.A	SMR Hybrid Glenoid System	Shoulder and Elbow	3/30/23	K163397	2	Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.
91842	Zimmer, Inc.	CoCr Femoral Head	Arthroplasty	3/29/23	K993259	2	Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009
91866	Biomet, Inc.	G7 Dual Mobility System	Arthroplasty	3/23/23	K150522	2	The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
91752	DePuy Orthopaedics, Inc.	ATTUNE Revision LPS Insert / Attune Posterior (PS) Fixed Bearing (FB) Tibial Inserts	Arthroplasty	3/17/23	K191779	2	The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
91613	Limacorporate S.p.A	TEMA Elbow System	Shoulder and Elbow	3/16/23	K181362	2	Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
91702	Synthes (USA) Products LLC	DePuy Synthes TFN-Advanced" Proximal Femoral Nailing System	Trauma	3/10/23	K131548	2	TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
91666	Stryker GmbH	Stryker Hoffmann LRF Bone Transport	Trauma	3/1/23	K153377	2	Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.
91494	Encore Medical, LP	EMPOWR VVC TIBIAL INSERT	Arthroplasty	2/27/23	K180930	2	Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size.
91673	Wright Medical Technology, Inc.	CLAW II Polyaxial Compression Plating System	Foot and Ankle	2/24/23	K113014	2	Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
91376	Conformis, Inc.	iTotal Identity Impactor Handle	Arthroplasty	2/13/23		2	Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.
91098	OrthoPediatrics Corp	Orthex External Fixation	Trauma; Pediatrics	02/10/23	K151881	2	Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
91098	OrthoPediatrics Corp	X-Fix Line Additions	Pediatrics; Trauma	2/10/23	K151881	2	Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
91526	Wishbone Medical, Inc.	WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device	Pediatrics; Trauma	2/7/23	K193368	2	Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.
91478	TriMed Inc.	RipCord Syndesmosis Button Kit	Sports	2/7/23	K220650	2	Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
91489	Biomet, Inc.	VANGUARD COMPLETE KNEE SYSTEM	Arthroplasty	1/30/23	K113550	2	Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
91423	Biomet, Inc.	Orthopedic Salvage System Modular Arthrodesis Nail	Tumor; Arthroplasty	1/27/23	K042409	2	Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
91365	Biomet, Inc.	OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT	Arthroplasty	1/26/23	K133940	2	Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
91261	Depuy Ireland UC	BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR	Arthroplasty	1/12/23	K943727	2	All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.
91109	CoreLink LLC	FLXfit	Spine	1/12/23	K171519	2	Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
90996	Acumed LLC	Acutrak and Mini Acutrak Fixation Screws	Hand; Foot and Ankle; Trauma	12/23/22	K221333	2	Distribution without Pre-Market Clearance
91196	NuVasive Inc	X-CORE 2 Ti Core part of NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM	Spine	12/20/22	K090176	2	Potential that insert will be unable to disengage from the vertebral body replacement device/implant
91174	Icotec Ag	VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0	Spine	12/19/22	K190545; K200596; K193423	2	During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.
91183	Corin Ltd	Corin BIOLOX Delta Modular Femoral Heads	Arthroplasty	12/19/22		2	The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
91125	NuVasive Specialized Orthopedics, Inc.	MAGEC® System	Spine	12/14/22	K201543	2	During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.
91073	Zimmer, Inc.	NexGen Option Stemmed Tibial Component	Arthroplasty	12/09/22	K872379	2	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) components as compared to other total knee arthroplasties in the United Kingdom National Joint Registry (UK NJR). Removing the NexGen Stemmed Option Tibial Component f rom inventory will prevent its future implantation with either the LPS Flex or LPS Flex GSF femoral components and mitigate the increased revision risk with these two specific combinations of tibial and femoral component.
91143	Arthrex, Inc.	Arthrex Osteochondral Autograft Transplantation	Sports Medicine	12/08/22		2	The devices may be packaged with the wrong reamer size.
91070	Integrity Implants Inc.	LineSider Spinal System	Spine	12/05/22	K203367	2	Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
91091	Medacta Usa Inc	NextAR RSA Platform	Shoulder and Elbow	12/02/22	K210153	2	A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.
91102	MicroPort Orthopedics Inc.	EVOLUTION MP Tibial Bases	Arthroplasty	11/22/22	K093552; K102380	2	One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
91039	Corin Ltd	Unity Total Knee System	Arthroplasty	11/21/22	K113060	2	The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
91044	Howmedica Osteonics Corp.	Simplex HV with Gentamicin US	Arthroplasty	11/15/22	K123081	2	Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)
90965	Wright Medical Technology, Inc.	Stryker INBONE Total Ankle System	Foot and Ankle	10/27/22	K051023	2	The tibial tray lock detail is oversized (larger than specification).
90882	Encore Medical, LP	EMPOWR Acetabular System; EMPOWER 3D Knee Tibial Insert	Arthroplasty	10/21/22	K190057; K190057	2	Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
90918	Synthes (USA) Products LLC	SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit	Foot and Ankle; Trauma	10/18/22	K142292	2	The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
90842	Synthes (USA) Products LLC	Hammertoe Continuous Compression Implant (CCI) Kit	Foot and Ankle	10/06/22	K191463	2	Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound
90858	Zimmer, Inc.	G7 Acetabular System	Arthroplasty	10/05/22	K121874	2	The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.
90772	Wright Medical Technology, Inc.	EVOLVE MODULAR RADIAL HEAD	Shoulder and Elbow	10/04/22	K060731; K991915	2	The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
90836	Howmedica Osteonics Corp.	Short tibial bearing MK4	Arthroplasty	09/23/22	K140898	2	A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.
90753	Paragon 28, Inc.	Grappler Suture Anchor System	Foot and Ankle; Sports Medicine	09/22/22	K211002	2	Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
90279	Exactech, Inc.	EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS	Arthroplasty	09/09/22	K040601; K040613;	2	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
90279	Exactech, Inc.	EXACTECH 12/14 TOTAL HIP SYSTEM	Arthroplasty	09/09/22	K041906	2	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
90279	Exactech, Inc.	ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE	Arthroplasty	09/09/22	K051556	2	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
90279	Exactech, Inc.	EXACTECH NOVATION CROWN CUP AND LINERS & CONSTRAINED	Arthroplasty	09/09/22	K070479; K071676	2	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
90279	Exactech, Inc.	NOVATION CROWN CUP GXL LINERS	Arthroplasty	09/09/22	K100269	2	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
90279	Exactech, Inc.	NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED	Arthroplasty	09/09/22	K121392	2	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
90279	Exactech, Inc.	EXACTECH ALL POLY ACETABULAR CUP	Arthroplasty	09/09/22	K963313	2	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
90279	Exactech, Inc.	EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT	Arthroplasty	09/09/22	K993082	2	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
90738	OrthoPediatrics Corp	Orthex External Fixation	Trauma; Pediatrics	09/06/22	K151881	2	Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
90662	Corin Ltd	TaperFit Stem	Arthroplasty	08/31/22	K142761	2	Some of the devices did not pass fatigue testing.
90670	New Standard Device Inc	Revolution External Fixation System	Trauma; Pediatrics	08/29/22	K181630	2	Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
90678	Aesculap Implant Systems LLC	Aesculap ENNOVATE SET SCREW STERILE	Spine	08/26/22	K180433	2	Potential for the incorrect screw to be included in the package.
90603	Mizuho OSI	Femoral Hook, Hana/ProFx Classic Femoral Hook Right	Arthroplasty	08/24/22		2	One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
90660	Wright Medical Technology, Inc.	SWANSON Flexspan Finger Joint Implant	Hand	08/23/22		2	An incorrect sizing label was applied to the carton packaging.
90573	Corin Ltd	Corin METAFIX HIP STEM	Arthroplasty	08/09/22	K153381; K082525	2	One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
90436	Paragon 28, Inc.	HammerTube Implant	Foot and Ankle	07/27/22	K171715	2	Due to Titanium plasma coating not present implant.
90478	Paragon 28, Inc.	Baby Gorilla/Gorilla Plating System	Foot and Ankle	07/25/22		2	Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
90500	NuVasive Inc	Simplify Cervical Artificial Disc	Spine	07/22/22	P200022	2	Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.
90557	DePuy Orthopaedics, Inc.	ATTUNE Measured Sizing and Rotation Guide	Arthroplasty	07/20/22		2	Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain
90544	Aesculap Implant Systems LLC	Modulift VBR Medium Set Screwdrivers	Spine	07/19/22		2	Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
90476	DePuy Orthopaedics, Inc.	Modular Cathcart Fracture Head Hip Ball	Arthroplasty	07/12/22	K903084	2	The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.
90399	Wright Medical Technology, Inc.	Wright EVOLVE TRIAD Plate Cutter	Trauma; Shoulder and Ebow	07/11/22		2	The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use
90390	DePuy Spine, Inc.	EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages	Spine	07/01/22	K170503	2	Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
90421	CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.	DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM	Hand; Trauma	06/28/22	K050932	2	One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
90216	Wright Medical Technology, Inc.	INFINITY TOTAL ANKLE SYSTEM	Foot and Ankle	06/27/22	K140749	2	The instrument is incorrectly color coded.
90159	New Standard Device Inc	Revolution External Plating System	Trauma; Pediatrics	06/21/22	K181630	2	Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
90230	Encore Medical, LP	EMPOWR 3D Kneetm INS	Arthroplasty	06/09/22	K143242	2	A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
90241	Howmedica Osteonics Corp.	Triathlon Tritanium Tibial component	Arthroplasty	06/03/22	K123486	2	Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
90140	MicroPort Orthopedics Inc.	PROFEMUR Z CLASSIC STEMS	Arthroplasty	06/02/22	K123434	2	One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
90052	Tornier, Inc	Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid	Shoulder and Elbow	06/01/22	K161742	2	The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
90118	Smith & Nephew, Inc.	TRIGEN INTERTAN	Trauma	5/25/22	K040212	2	Right nails were anodized, marked, and labelled as left nails and vice versa
89868	American Contract Systems	Orthopedic Tray	Hand	5/6/22		2	Product was sterilized with a higher than specification EO concentration.
89959	DePuy	VELYS™ Robotic-Assisted Solution	Arthroplasty	5/2/22	K202769	2	System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment
89983	restor3d Inc.	Non-Sterile Double Ended Trial Kit	Spine	4/29/22		2	Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
89764	Nextremity Solutions	FLEXFUSION (TM) FIXATION IMPLANT	Foot and Ankle	4/12/22	K110445	2	Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
89672	Stradis Medical	Anterior Hip Pack - Surgical Kit	Arthroplasty	4/4/22		2	The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
89671	Stradis Medical	Total Knee Pack - Surgical Kit	Arthroplasty	4/4/22		2	The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
89619	Zimmer	NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE	Arthroplasty	3/3/22	K110054	2	The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.
89428	Synthes	Universal Chuck	Trauma	2/10/22		2	Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.
89454	DePuy	ATTUNE Revision Knee System	Arthroplasty	2/9/22	K160700	2	May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
89177	Ellipse Technologies	ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	Spine	1/26/22	K140178	2	Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
89240	DePuy	DEPUY GLOBAL UNITE SHOULDER SYSTEM GLOBAL UNITE Platform Shoulder System	Shoulder and Elbow	1/11/22	K101996; K170748	2	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
89092	Conventus Orthopaedics	Flex-ThreadTM Distal Fibula Intramedullary Nail System	Foot and Ankle; Trauma	1/3/22	K202858	2	Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available
93924	Synthes (USA) Products LLC	VALCP Clavicle Plate	Shoulder and Elbow; Sports Medicine	3/1/24	K201321	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	OPAL Intervertebral Cage	Spine	3/1/24		2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	Synthes Hindfoot Arthrodesis Nail System	Foot and Ankle	3/1/24	K051678	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	Synthes TFNA	Trauma	3/1/24	K160167, K131548	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	Synthes RIA System	Trauma; Pediatrics	3/1/24	K111437 ; K042899 ; K013527	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	Synthes TFNA	Trauma	3/1/24	K160167 ; K131548	2	Products not sterilized, sterility cannot be confirmed
93858	United Orthopedic Corporation	USTAR II Hip System PressFit Curved Stem, RHS Ti Plasma Spray	Arthroplasty	2/29/24	K190100	2	Their is a potential that the implant curved stem may be oriented incorrectly.
93878	Acumed LLC	Acumed AcuLoc and AcuLoc 2 Wrist Plating Systems	Hand; Sports Medicine	2/29/24		2	Distribution without Pre-Market Clearance
93858	United Orthopedic Corporation	USTAR II Knee System PressFit Curved Stem, RHS Ti Plasma Spray	Arthroplasty	2/29/24	K190100	2	Their is a potential that the implant curved stem may be oriented incorrectly.
93858	United Orthopedic Corporation	USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray	Arthroplasty	2/29/24	K190100	2	Their is a potential that the implant curved stem may be oriented incorrectly.
93944	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK BiMobile Dual Mobility System EPoly Liner for 28mm Head, 70mm Shell	Arthroplasty	2/29/24	K190535	2	Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
93898	Alphatec Spine, Inc.	IdentiTi ALIF Standalone Interbody System	Spine	2/23/24	K232097	2	Due to reports of intraoperative graft bolt implantation breakages.
94092	Exactech, Inc.	Exactech Equinoxe	Shoulder and Elbow; Arthroplasty	3/29/24	K113309	2	The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
94222	DePuy Orthopaedics, Inc.	ATTUNE KNEE SYSTEM TIBIAL BASE AFFIXIUM FIXED BEARING SIZE 6	Arthroplasty	3/29/24	K202194 ; K213781 ; K232303	2	Product incorrectly labelled.
94078	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SPII Model Lubinus, Hip Prosthesis Stem	Arthroplasty	3/14/24	K953653	2	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
94078	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SPII Model Lubinus, Hip Prosthesis Stem	Arthroplasty	3/14/24	K953653	2	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
94078	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SPII Model Lubinus, Hip Prosthesis Stem	Arthroplasty	3/14/24	K953653	2	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
94078	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SPII Model Lubinus, Hip Prosthesis Stem	Arthroplasty	3/14/24	K953653	2	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
92500	Waldemar Link GmbH & Co. KG (Mfg Site)	EndoModel Modular Knee Prosthesis System	Arthroplasty	6/30/23	K143179	2	The firm discovered through customer complaints that device segments may not meet specifications.
92500	Waldemar Link GmbH & Co. KG (Mfg Site)	EndoModel Modular Knee Prosthesis System	Arthroplasty	6/30/23	K143179	2	The firm discovered through customer complaints that device segments may not meet specifications.
92500	Waldemar Link GmbH & Co. KG (Mfg Site)	EndoModel Modular Knee Prosthesis System	Arthroplasty	6/30/23	K143179	2	The firm discovered through customer complaints that device segments may not meet specifications.
92500	Waldemar Link GmbH & Co. KG (Mfg Site)	EndoModel Modular Knee Prosthesis System	Arthroplasty	6/30/23	K143179	2	The firm discovered through customer complaints that device segments may not meet specifications.
93507	Exactech, Inc.	Exactech Opetrak	Arthroplasty	1/18/24	K160484 ; K932690 ; K933610 ; K954208	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Truliant	Arthroplasty	1/18/24	K152170 ; K171045	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Alteon	Arthroplasty	1/18/24	K182502	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Equinoxe	Shoulder and Elbow; Arthroplasty	1/18/24	K212356	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Novation	Arthroplasty	1/18/24	K071676	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech AcuMatch	Arthroplasty	1/18/24	K173583	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Vantage	Arthroplasty	1/18/24		2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Equinoxe Reverse Shoulder System	Shoulder and Elbow	1/18/24	K093275; K180632; K182536; K063569	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak Logic	Arthroplasty	1/18/24	K111400; K150890	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak Logic PS	Arthroplasty	1/18/24	K033883	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Vantage	Foot and Ankle	1/18/24	K152217	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
94276	Zimmer, Inc.	Zimmer Periarticular Locking Plate System Distal Lateral Fibula Locking Plate	Trauma; Foot and Ankle; Sports Medicine	4/30/24	K070906	2	Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss
94306	SEASPINE ORTHOPEDICS CORPORATION	Mariner RDX MIS Polyaxial Head	Spine; Sports Medicine	4/23/24	K222110	2	Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
94164	SEASPINE ORTHOPEDICS CORPORATION	SeaSpine Mariner RDX System	Spine; Trauma; Sports Medicine	4/22/24	K222110	2	Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
94310	Biomet, Inc.	Vanguard Anterior Stabilized Tibial Bearing	Arthroplasty	4/22/24	K050222	2	Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
94327	Zimmer, Inc.	NexGen CRFlex Porous Femur	Arthroplasty	4/22/24	K031061	2	Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
94288	Conformis, Inc.	Identity Imprint PS Tibial Tray	Arthroplasty	4/17/24	K210191; K231233	2	Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
92776	Alphatec Spine, Inc.	LIF AMP, Adjustable Awl	Spine	8/28/23		2	Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.
92767	Smith & Nephew, Inc.	smith&nephew TRIGEN	Trauma; Sports Medicine	8/22/23	K210980; K040462	2	A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
92767	Smith & Nephew, Inc.	smith&nephew TRIGEN	Trauma; Sports Medicine	8/22/23	K040462; K210980	2	A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
92758	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK MP Monoblock Trial Stem Instruments, Sizes 14mm 25mm	Arthroplasty; Trauma	8/4/23	K183141	2	Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
92969	Encore Medical, LP	DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 35202106	Arthroplasty	9/19/23	K173723	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 50801032;	Shoulder and Elbow	9/19/23	K051075	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: Delta Ceramic Femoral Head, 44 mm 4.0 mm, REF: 40003443	Arthroplasty	9/19/23	K082844	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size3, REF: 42611030	Arthroplasty	9/19/23	K052320	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 53306108	Shoulder and Elbow	9/19/23	K172351	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
94555	Smith & Nephew Inc	OXINIUM	Arthroplasty	5/24/24	K022958; K021673	2	Packaging contained the incorrect size of femoral head from what was displayed on the label.
94405	Wishbone Medical, Inc.	WishFIX Growth Control Plating System	Pediatrics	5/10/24	K182704	2	The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.
93323	Biomet, Inc.	Zimmer	Arthroplasty; Trauma	11/21/23	K062998	2	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
93323	Biomet, Inc.	OSSTM Compress & Mini Compress Anchor Plugs	Arthroplasty; Trauma; Sports Medicine	11/21/23	K062998	2	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
93748	TriMed Inc.	Volar Bearing Plate	Hand; Trauma; Sports Medicine	1/31/24	K222637	2	Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio NRG Tibial Brg Insert Assy	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DURATION A-P LIPPED TIB.INSERT-DURAC	Arthroplasty	1/31/24	K032163; K032418; K915512	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DURATION PLASTIC PATELLA-DURACON	Arthroplasty	1/31/24	K032163; K032418; K915512	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DUR PCA MTK REV INS LFT	Arthroplasty	1/31/24	K894403; K972863	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DUR PCA MTK REV INS LFT	Arthroplasty	1/31/24	K894403; K972863	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO RECESSED PATELLA	Arthroplasty	1/31/24	K863668	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DURATION A-P LIPPED TIB.INSERT-DURAC	Arthroplasty	1/31/24	K032163; K032418; K915512	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO RECESSED PATELLA	Arthroplasty	1/31/24	K863668	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy	Arthroplasty	1/31/24	K011643	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	P7 32MM 1O DEGREE +4MM INSERT	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO RECESSED PATELLA	Arthroplasty	1/31/24	K863668	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DUR PCA MTK REV INS RT	Arthroplasty	1/31/24	K894403; K972863	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	PS LIPPED TIBIAL INSERT ASSY DURACON	Arthroplasty	1/31/24	K012172	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	PS LIPPED TIBIAL INSERT ASSY DURACON	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SERIES II TIBIAL BEAR INSERT	Arthroplasty	1/31/24	K884398	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	PRIMARY REV.TIB.INSERT-DURACON	Arthroplasty	1/31/24	K936008	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LARGE PRIMARY REV.TIB.INSERT- DURACON	Arthroplasty	1/31/24	K936008	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	PS LIPPED TIBIAL INSERT ASSY DURACON	Arthroplasty	1/31/24	K012172	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy	Arthroplasty	1/31/24	K041591	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	K051948; K052917; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio NRG Tibial Brg Insert Assy	Arthroplasty	1/31/24	K030978	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	OSTEONICS TRIDENT 0 deg POLY INSERT	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DUR PCA MTK REV INS RT	Arthroplasty	1/31/24	K894403; K972863	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	TIBIAL BEARING INSERT SERIES P-S I ASSY	Arthroplasty	1/31/24	K914565	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO RECESSED PATELLA-	Arthroplasty	1/31/24	K863668	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy	Arthroplasty	1/31/24	K011643	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	OSTEONICS TRIDENT 0 deg POLY INSERT	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SERIES II TIBIAL BEAR INSERT	Arthroplasty	1/31/24	K884398	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	P7 28MM 10 DEGREE +4MM INSERT	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93738	XTANT Medical Holdings, Inc	Cortera Spinal Fixation System	Spine	1/29/24	K221403	2	Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
93729	FX SHOULDER	CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10 TILT 32mm	Shoulder and Elbow	1/29/24	K191146	2	Centered glenosphere box may contain an eccentric glenosphere.
93662	Waldemar Link GmbH & Co. KG (Mfg Site)	Link EndoModel Patella Glide Resection Guide	Arthroplasty	1/18/24		2	Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time
93650	Zimmer Biomet Spine Inc.	Vitality Spinal Fixation System	Spine	1/4/24	K150896	2	Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.
93623	Encore Medical, LP	Reverse Shoulder System e, RSP Humeral Socket Insert	Shoulder and Elbow; Sports Medicine	1/2/24	K051075	2	Mislabeling
93623	Encore Medical, LP	Domed TriPeg Patella, 38x9mm, E	Arthroplasty	1/2/24	K113756	2	Mislabeling
93507	Exactech, Inc.	Exactech Novation	Arthroplasty	1/18/24	K071676	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak	Arthroplasty	1/18/24	K160484; K932690; K933610; K954208	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Truliant	Arthroplasty	1/18/24	K152170; K171045	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Alteon	Arthroplasty	1/18/24	K182502	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Truliant, ActivitE	Arthroplasty	1/18/24	K223252	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Equinoxe	Shoulder and Elbow; Sports Medicine	1/18/24	K212356	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Vantage	Foot and Ankle	1/18/24	K152217	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech AcuMatch	Arthroplasty	1/18/24	K173583	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Vantage	Foot and Ankle	1/18/24		2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Equinoxe Reverse Shoulder System	Shoulder and Elbow; Sports Medicine	1/18/24	K093275; K180632; K182536; K063569	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak Logic	Arthroplasty	1/18/24	K111400; K150890	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak Logic PS	Arthroplasty	1/18/24	K033883	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93163	Medtronic Sofamor Danek USA Inc	GRAFTON DBM	Trauma	10/25/23	K051195	2	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
93156	Smith & Nephew, Inc.	JOURNEY II BCS	Arthroplasty	10/24/23	K140555; K111711	2	The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
93156	Smith & Nephew, Inc.	JOURNEY II BCS	Arthroplasty	10/24/23	K111711; K140555	2	The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
93080	Encore Medical, LP	REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP	Shoulder and Elbow	10/12/23	K041066	2	Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
93098	Encore Medical, LP	EMPOWR 3D Knee System	Arthroplasty	10/12/23	K143242	2	Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
93024	Flower Orthopedics Corporation	FlexThread TM 3.2mm Cannulated Reamer	Trauma	10/6/23	K202858	2	Device is breaking while in use, potential for patients to require a revision surgery.
92681	Zimmer, Inc.	Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length	Trauma; Sports Medicine	7/28/23	K141734	2	Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock.
92621	Materialise N.V.	MRI Biomet Pin Guide for Total Knee Arthroplasty	Arthroplasty	7/20/23	K173445; K221337	2	The wrong tibia guide was included intended for a different patient case.
92567	Medtronic Sofamor Danek USA Inc	Catalyft" LS Expandable Interbody System Anterior Standalone Cage	Spine	7/10/23	K212653	2	There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
92496	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SymphoKnee System Distal Femoral Augment	Arthroplasty	7/3/23	K202924	2	Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
92286	Smith & Nephew, Inc.	ENGAGE Cementless Partial Knee System	Arthroplasty	5/31/23	K190439	2	Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
92257	Stryker Orthopaedics	Triathlon Total Knee System	Arthroplasty	5/30/23	K173849	2	Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
92088	Linkbio Corp.	LINK SLED Knee System:	Arthroplasty	5/4/23	K954186	2	Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
92078	Wright Medical Technology, Inc.	stryker ORTHOLOC 3Di Fusion Plate MTP	Foot and Ankle	4/26/23	K120359	2	Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
91973	SPINEART SA	Juliet® Ti LL Lumbar Interbody Device	Spine	4/24/23	K190877	2	JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay.
91947	Medacta Usa Inc	MectaLIF Anterior Extension	Spine	4/19/23	K221545	2	There is a potential for breakage of the small screw used to affix the anti-backout plate.
91974	Smith & Nephew, Inc.	JOURNEY II UNI XLPE TIBIA INSERT	Arthroplasty	4/14/23	K190085	2	A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
91906	Encore Medical, LP	EMPOWR Porous Patella	Arthroplasty	4/12/23	K212941	2	Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.
91913	MAKO SURGICAL CORPORATION	MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM; RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM	Arthroplasty	4/12/23	K082172; K090763	2	Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
91869	Limacorporate S.p.A	SMR Hybrid Glenoid System	Shoulder and Elbow	3/30/23	K163397	2	Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.
91842	Zimmer, Inc.	CoCr Femoral Head	Arthroplasty	3/29/23	K993259	2	Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009
91866	Biomet, Inc.	G7 Dual Mobility System	Arthroplasty	3/23/23	K150522	2	The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
91752	DePuy Orthopaedics, Inc.	ATTUNE Revision LPS Insert / Attune Posterior (PS) Fixed Bearing (FB) Tibial Inserts	Arthroplasty	3/17/23	K191779	2	The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
91613	Limacorporate S.p.A	TEMA Elbow System	Shoulder and Elbow	3/16/23	K181362	2	Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
91702	Synthes (USA) Products LLC	DePuy Synthes TFN-Advanced" Proximal Femoral Nailing System	Trauma	3/10/23	K131548	2	TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
91666	Stryker GmbH	Stryker Hoffmann LRF Bone Transport	Trauma	3/1/23	K153377	2	Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.
93924	Synthes (USA) Products LLC	VALCP Clavicle Plate	Shoulder and Elbow; Sports Medicine	3/1/24	K201321	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	OPAL Intervertebral Cage	Spine	3/1/24		2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	Synthes Hindfoot Arthrodesis Nail System	Foot and Ankle	3/1/24	K051678	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	Synthes TFNA	Trauma	3/1/24	K131548 ; K160167	2	Products not sterilized, sterility cannot be confirmed
93924	Synthes (USA) Products LLC	Synthes RIA System	Trauma; Pediatrics	3/1/24	K013527 ; K042899 ; K111437	2	Products not sterilized, sterility cannot be confirmed
93858	United Orthopedic Corporation	USTAR II Hip System PressFit Curved Stem, RHS Ti Plasma Spray	Arthroplasty	2/29/24	K190100	2	Their is a potential that the implant curved stem may be oriented incorrectly.
93878	Acumed LLC	Acumed AcuLoc and AcuLoc 2 Wrist Plating Systems	Hand; Sports Medicine	2/29/24		2	Distribution without Pre-Market Clearance
93858	United Orthopedic Corporation	USTAR II Knee System PressFit Curved Stem, RHS Ti Plasma Spray	Arthroplasty	2/29/24	K190100	2	Their is a potential that the implant curved stem may be oriented incorrectly.
93858	United Orthopedic Corporation	USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray	Arthroplasty	2/29/24	K190100	2	Their is a potential that the implant curved stem may be oriented incorrectly.
93944	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK BiMobile Dual Mobility System EPoly Liner for 28mm Head, 70mm Shell	Arthroplasty	2/29/24	K190535	2	Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
93898	Alphatec Spine, Inc.	IdentiTi ALIF Standalone Interbody System	Spine	2/23/24	K232097	2	Due to reports of intraoperative graft bolt implantation breakages.
94092	Exactech, Inc.	Exactech Equinoxe	Shoulder and Elbow; Arthroplasty	3/29/24	K113309	2	The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
94222	DePuy Orthopaedics, Inc.	ATTUNE KNEE SYSTEM TIBIAL BASE AFFIXIUM FIXED BEARING SIZE 6	Arthroplasty	3/29/24	K202194 ; K213781 ; K232303	2	Product incorrectly labelled.
94078	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SPII Model Lubinus, Hip Prosthesis Stem	Arthroplasty	3/14/24	K953653	2	Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
92500	Waldemar Link GmbH & Co. KG (Mfg Site)	EndoModel Modular Knee Prosthesis System	Arthroplasty	6/30/23	K143179	2	The firm discovered through customer complaints that device segments may not meet specifications.
93507	Exactech, Inc.	Exactech Vantage	Foot and Ankle	1/18/24	K152217	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
94276	Zimmer, Inc.	Zimmer Periarticular Locking Plate System Distal Lateral Fibula Locking Plate	Trauma; Foot and Ankle; Sports Medicine	4/30/24	K070906	2	Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss
94306	SEASPINE ORTHOPEDICS CORPORATION	Mariner RDX MIS Polyaxial Head	Spine; Sports Medicine	4/23/24	K222110	2	Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
94164	SEASPINE ORTHOPEDICS CORPORATION	SeaSpine Mariner RDX System	Spine; Trauma; Sports Medicine	4/22/24	K222110	2	Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
94310	Biomet, Inc.	Vanguard Anterior Stabilized Tibial Bearing	Arthroplasty	4/22/24	K050222	2	Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
94327	Zimmer, Inc.	NexGen CRFlex Porous Femur	Arthroplasty	4/22/24	K031061	2	Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
94288	Conformis, Inc.	Identity Imprint PS Tibial Tray	Arthroplasty	4/17/24	K210191 ; K231233	2	Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
92776	Alphatec Spine, Inc.	LIF AMP, Adjustable Awl	Spine	8/28/23		2	Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.
92767	Smith & Nephew, Inc.	smith&nephew TRIGEN	Trauma; Sports Medicine	8/22/23	K040462 ; K210980	2	A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
92758	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK MP Monoblock Trial Stem Instruments, Sizes 14mm 25mm	Arthroplasty; Trauma	8/4/23	K183141	2	Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
92969	Encore Medical, LP	DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 35202106	Arthroplasty	9/19/23	K173723	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 50801032;	Shoulder and Elbow	9/19/23	K051075	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: Delta Ceramic Femoral Head, 44 mm 4.0 mm, REF: 40003443	Arthroplasty	9/19/23	K082844	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size3, REF: 42611030	Arthroplasty	9/19/23	K052320	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
92969	Encore Medical, LP	DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 53306108	Shoulder and Elbow	9/19/23	K172351	2	Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
94555	Smith & Nephew Inc	OXINIUM	Arthroplasty	5/24/24	K021673 ; K022958	2	Packaging contained the incorrect size of femoral head from what was displayed on the label.
94405	Wishbone Medical, Inc.	WishFIX Growth Control Plating System	Pediatrics	5/10/24	K182704	2	The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.
93323	Biomet, Inc.	Zimmer	Arthroplasty; Trauma	11/21/23	K062998	2	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
93323	Biomet, Inc.	OSSTM Compress & Mini Compress Anchor Plugs	Arthroplasty; Trauma; Sports Medicine	11/21/23	K062998	2	Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
93748	TriMed Inc.	Volar Bearing Plate	Hand; Trauma; Sports Medicine	1/31/24	K222637	2	Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio NRG Tibial Brg Insert Assy	Arthroplasty	1/31/24	K051948 ; K052917 ; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DURATION A-P LIPPED TIB.INSERT-DURAC	Arthroplasty	1/31/24	K032163 ; K032418 ; K915512	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DURATION PLASTIC PATELLA-DURACON	Arthroplasty	1/31/24	K032163 ; K032418 ; K915512	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DUR PCA MTK REV INS LFT	Arthroplasty	1/31/24	K894403 ; K972863	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO RECESSED PATELLA	Arthroplasty	1/31/24	K863668	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO U-DOME PATELLA	Arthroplasty	1/31/24	K051948 ; K052917 ; K972967	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TS TIB INSERT	Arthroplasty	1/31/24	K994128	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy	Arthroplasty	1/31/24	K011643	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	P7 32MM 1O DEGREE +4MM INSERT	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	DUR PCA MTK REV INS RT	Arthroplasty	1/31/24	K894403 ; K972863	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	PS LIPPED TIBIAL INSERT ASSY DURACON	Arthroplasty	1/31/24	K012172	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SERIES II TIBIAL BEAR INSERT	Arthroplasty	1/31/24	K884398	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	PRIMARY REV.TIB.INSERT-DURACON	Arthroplasty	1/31/24	K936008	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LARGE PRIMARY REV.TIB.INSERT- DURACON	Arthroplasty	1/31/24	K936008	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	OSTEONICS TRIDENT 0 deg POLY INSERT	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	TIBIAL BEARING INSERT SERIES P-S I ASSY	Arthroplasty	1/31/24	K914565	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO RECESSED PATELLA-	Arthroplasty	1/31/24	K863668	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11	Arthroplasty	1/31/24	K962152	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT	Arthroplasty	1/31/24	K940861	2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93687	Howmedica Osteonics Corp.	P7 28MM 10 DEGREE +4MM INSERT	Arthroplasty	1/31/24		2	Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
93738	XTANT Medical Holdings, Inc	Cortera Spinal Fixation System	Spine	1/29/24	K221403	2	Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
93729	FX SHOULDER	CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TiN 10 TILT 32mm	Shoulder and Elbow	1/29/24	K191146	2	Centered glenosphere box may contain an eccentric glenosphere.
93662	Waldemar Link GmbH & Co. KG (Mfg Site)	Link EndoModel Patella Glide Resection Guide	Arthroplasty	1/18/24		2	Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time
93650	Zimmer Biomet Spine Inc.	Vitality Spinal Fixation System	Spine	1/4/24	K150896	2	Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.
93623	Encore Medical, LP	Reverse Shoulder System e, RSP Humeral Socket Insert	Shoulder and Elbow; Sports Medicine	1/2/24	K051075	2	Mislabeling
93623	Encore Medical, LP	Domed TriPeg Patella, 38x9mm, E	Arthroplasty	1/2/24	K113756	2	Mislabeling
93507	Exactech, Inc.	Exactech Novation	Arthroplasty	1/18/24	K071676	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak	Arthroplasty	1/18/24	K160484 ; K932690 ; K933610 ; K954208	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Truliant	Arthroplasty	1/18/24	K152170 ; K171045	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Alteon	Arthroplasty	1/18/24	K182502	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Truliant, ActivitE	Arthroplasty	1/18/24	K223252	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Equinoxe	Shoulder and Elbow; Sports Medicine	1/18/24	K212356	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech AcuMatch	Arthroplasty	1/18/24	K173583	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Equinoxe Reverse Shoulder System	Shoulder and Elbow; Sports Medicine	1/18/24	K063569 ; K093275 ; K180632 ; K182536	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak Logic	Arthroplasty	1/18/24	K111400 ; K150890	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93507	Exactech, Inc.	Exactech Opetrak Logic PS	Arthroplasty	1/18/24	K033883	2	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
93163	Medtronic Sofamor Danek USA Inc	GRAFTON DBM	Trauma	10/25/23	K051195	2	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
93156	Smith & Nephew, Inc.	JOURNEY II BCS	Arthroplasty	10/24/23	K111711 ; K140555	2	The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
93080	Encore Medical, LP	REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP	Shoulder and Elbow	10/12/23	K041066	2	Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
93098	Encore Medical, LP	EMPOWR 3D Knee System	Arthroplasty	10/12/23	K143242	2	Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
93024	Flower Orthopedics Corporation	FlexThread TM 3.2mm Cannulated Reamer	Trauma	10/6/23	K202858	2	Device is breaking while in use, potential for patients to require a revision surgery.
92681	Zimmer, Inc.	Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length	Trauma; Sports Medicine	7/28/23	K141734	2	Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock.
92621	Materialise N.V.	MRI Biomet Pin Guide for Total Knee Arthroplasty	Arthroplasty	7/20/23	K173445 ; K221337	2	The wrong tibia guide was included intended for a different patient case.
92567	Medtronic Sofamor Danek USA Inc	Catalyft" LS Expandable Interbody System Anterior Standalone Cage	Spine	7/10/23	K212653	2	There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
92496	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SymphoKnee System Distal Femoral Augment	Arthroplasty	7/3/23	K202924	2	Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
95566	Karl Storz Endoscopy	Karl Storz Powershaver System S2	Sports	11/25/24	K030009	2	Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
94410	Exactech, Inc.	Exactech AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Line	Total Joints	6/28/24	K013211	2	The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.
94445	Medartis Inc.	2.8 TriLock Screw	Foot / Ankle	5/14/24	K091479	2	Screw is 16mm long instead of 22mm long.
95274	Stryker Spine	AVS Anchor-C Cervical Cage System	Spine	9/23/24	K102606	2	Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.
95066	Intrinsic Therapeutics, Inc.	Barricaid Impactor	Spine	8/20/24		2	At least two units have been found to be missing a weld.
95231	Zimmer GmbH	Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck	Total Joints	9/12/24	K082996	2	Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
95231	Zimmer GmbH	Biolox Option Taper Sleeve, Type 1 Taper	Total Joints	9/12/24	K082996	2	Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
95654	Smith & Nephew Inc.	BIORAPTOR Suture Anchor	Sports	11/29/24	K152566 ; K071586	2	Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
95760	SEASPINE ORTHOPEDICS CORPORATION	Daytona Small Stature	Spine	12/23/24	K232566	2	Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
95661	Cartiva, Inc	Cartiva	Hand	12/4/24	P150017	2	Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation.
95395	XTANT Medical Holdings, Inc	XTANT Medical Holdings, Inc	Spine	10/17/24	K221403	2	Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
94923	Zimmer, Inc.	CPT	Total Joint	7/30/24	K960658	2	Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
95114	Howmedica Osteonics Corp.	Custom Made Device - GMRS EXTENSION Piece 40MM LEFT	Joints	8/26/24	K222056 ; K023087	2	A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
95154	Smith & Nephew, Inc.	K-WIRE	Trauma	9/19/24		2	Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
96019	Encore Medical, LP	EMPOWR 3D KNEE	Arthroplasty	12/26/24	K143242	2	5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
95882	Encore Medical, LP	EMPOWR 3D Knee Tibial Insert	Arthroplasty	12/23/24	K143242	2	Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
94814	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK Endo Model M and Endo Model SL Tibial Components	Arthroplasty	7/18/24	K143179 ; K151008 ; K212742	2	Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
95672	MicroPort Orthopedics Inc.	EVOLUTION MP FEMORAL COMPONENT	Arthroplasty	12/18/24	K093552 ; K102380 ; K140735	2	Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
94729	MicroPort Orthopedics Inc.	EVOLUTION MP Femoral CS/CR Non-Porous	Arthroplasty	7/1/24	K093552 ; K102380	2	One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.
95933	Waldemar Link GmbH & Co. KG (Mfg Site)	Link Bio	Arthroplasty	12/26/24	K142187	2	Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
95887	Moximed, Inc.	MISHA Knee System Implant	Arthroplasty	12/23/24		2	Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.
94977	Treace Medical Concepts, Inc.	Nanoplasty 3D Bunion Correction System Implant	Foot and Ankle	8/23/24	K240173	2	Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates.
95598	Novosource, LLC	NovoHip Total Hip System	Arthroplasty	11/18/24	K132158	2	Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted
94409	Exactech, Inc.	OPTETRAK	Arthroplasty	6/18/24	K160484 ; K932690 ; K933610	2	Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
94257	SPINEART SA	PERLA TL 25D SCREW	Spine	5/3/24	K193396	2	Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but position askew
95567	NuVasive Specialized Orthopedics, Inc.	Precice Max	Trauma	11/21/24	K232267	2	Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
95164	Centinel Spine, Inc.	prodisc	Spine	9/24/24	P070001S019	2	During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
94742	Biomet, Inc.	RingLoc Bi-Polar Hip System Acetabular Cup	Arthroplasty	6/25/24	K051569	2	41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
95178	Smith & Nephew Inc.	ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)	Sports Medicine; Shoulder and Elbow; Trauma	9/10/24	K131637	2	Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
95178	Smith & Nephew Inc.	ROTATION MEDICAL TENDON STAPLES (8) (broad indication)	Sports Medicine; Shoulder and Elbow; Trauma	9/10/24	K131637	2	Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
95494	Smith & Nephew Inc	Smith & Nephew Genesis II	Arthroplasty	10/31/24	K962557	2	Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
95494	Smith & Nephew Inc	Smith & Nephew Legion Oxinium	Arthroplasty	10/31/24	K112941	2	Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
95493	Smith & Nephew Inc	smith & Nephew Legion	Arthroplasty	10/30/24	K043440	2	Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
94555	Smith & Nephew Inc	OXINIUM	Arthroplasty	5/24/24	K021673 ; K022958	2	Packaging contained the incorrect size of femoral head from what was displayed on the label.
95245	Tornier, Inc	Stryker Tornier Perform	Shoulder and Elbow	9/27/24	K201315	2	Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
95568	Smith & Nephew, Inc.	Tandem Intl	Arthroplasty	11/7/24	K023743 ; K211176 ; K231448	2	The Bipolar assembly contains an oversized Retainer Ring.
95732	Limacorporate S.p.A	TEMA ELBOW - AXLE	Shoulder and Elbow	12/20/24	K222807	2	Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
95315	Howmedica Osteonics Corp.	Triathlon Universal TS Baseplate Size 2	Arthroplasty	10/7/24	K141056	2	Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
94381	TriMed Inc.	Threaded IM Nail System	Trauma	5/10/24	K234040	2	Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
94381	TriMed Inc.	Threaded IM Nail	Trauma	5/10/24	K234040	2	Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
95185	Innovasis, Inc	TxHA PEEK IBF System; TxTiHA IBF System	Spine	9/17/24	K180078 ; K183064 ; K201614	2	Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
94871	Howmedica Osteonics Corp.	Stryker	Arthroplasty	7/16/24	K014226	2	Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
96009	Alphatec Spine, Inc.	Alphatec	spine	1/30/25	K232504	2	Under Investigation by firm
96063	LivaNova USA, Inc.	SenTiva DUO"	spine	1/31/25	P970003	2	Device Design
96090	Zimmer, Inc.	NexGen LCCK	Arthroplasty; Trauma	2/1/25	K960279	2	Process change control
96090	Zimmer, Inc.	NexGen LCCK	Arthroplasty; Trauma	2/2/25	K960279	2	Process change control
95970	Medtronic Navigation, Inc.	Sterile Percutaneous Pin	Spine	2/3/25	K131425	2	Under Investigation by firm
96099	Integrity Implants Inc.	Repeater Bone Tamp	Spine	2/4/25	K182114	2	Device Design
95998	Stryker Corporation	Stryker 3.0MM Prec Neuro Match Hea	Spine	2/5/25	K143320	2
95998	Stryker Corporation	Stryker 3.0MM Neuro Match Head	Spine	2/6/25	K143320	2	Process control
95996	Stryker Corporation	Stryker 3.0MM Neuro Match Head Soft Touch	Spine	2/7/25	K143320	2	Process control
95981	IsoTis OrthoBiologics, Inc.	OsteoSurge 100 Demineralized Bone Matrix Putty	Spine; Arthroplasty	2/8/25	K242273	2	Labeling Change Control
95978	IsoTis OrthoBiologics, Inc.	OsteoCove Putty	Spine	2/9/25	K242273	2	Under Investigation by firm
96030	Tornier S.A.S.	Stryker Blueprint	Shoulder and elbow	2/10/25	K222510	2	Device Design
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/11/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/12/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/13/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/14/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/15/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/16/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/17/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/18/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/19/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/20/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/21/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/22/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/23/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/24/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/25/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/26/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/27/25	K232652	2	Process control
96212	Tyber Medical	A.L.P.S. mvX	Trauma	2/28/25	K232652	2	Process control
96179	XTANT Medical Holdings, Inc	Irix-A Lumbar Integrated Fusion System	Spine	3/1/25	K171567	2	Labeling Change Control
96102	Exactech, Inc.	AcuMatch XLE	Arthroplasty	3/2/25	K173583	2	Nonconforming Material/Component
96102	Exactech, Inc.	Novation XLE	Arthroplasty	3/3/25	K173583	2	Nonconforming Material/Component
96102	Exactech, Inc.	Alteon XLE	Arthroplasty	3/4/25	K182502	2	Nonconforming Material/Component
96098	Stryker Corporation	stryker Precision Thin	Foot and Ankle; Shoulder and Elbow; Arthroplasty	3/5/25	K143145	2	Process control
96098	Stryker Corporation	stryker Precision Thin	Foot and Ankle; Shoulder and Elbow; Arthroplasty	3/6/25	K143145	2	Process control
96127	Ethicon, LLC	PERMA-HAND Silk Suture	Hand	3/7/25	K946173	2	Process control
96387	Checkpoint Surgical Inc	Checkpoint Guardian Intraoperative Lead	Hand	3/8/25	K212355	2	Process control
96400	Zimmer, Inc.	NexGen LPS Flex	Arthroplasty	3/9/25	K042271	2	Labeling Change Control
96351	Orthofix U.S. LLC	PILLAR SA Ti Spacer System	Spine	3/10/25	K240749	2	Labeling Change Control
96398	ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY	Comprehensive Shoulder	Shoulder and Elbow	3/11/25	K193038	2	Nonconforming Material/Component
96386	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SymphoKnee Modular Stem	Arthroplasty	3/12/25	K202924	2	Labeling Change Control
96386	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SymphoKnee Modular Stem	Arthroplasty	3/13/25	K202924	2	Labeling Change Control
96386	Waldemar Link GmbH & Co. KG (Mfg Site)	LINK SymphoKnee Modular Stem	Arthroplasty	3/14/25	K202924	2	Labeling Change Control
96401	MEDLINE INDUSTRIES, LP - Northfield	Proxima Drape	Hand	3/15/25		2	Packaging process control
96401	MEDLINE INDUSTRIES, LP - Northfield	Proxima Drape	Shoulder and Elbow	3/16/25	K213481	2	Packaging process control
96348	Zimmer, Inc.	Z1 Femoral Hip System	Arthroplasty	3/17/25	K233476	2	Under Investigation by firm
96281	Stryker Corporation	inchLock Flex Knotless Anchor with Inserter and Suture	Arthroplasty; Shoulder and Elbow	3/18/25	K151314	2	Under Investigation by firm
96643	Waldemar Link GmbH & Co. KG (Mfg Site)	LinkSymphoKnee	Arthroplasty	3/19/25	K202924	2	Nonconforming Material/Component
96643	Waldemar Link GmbH & Co. KG (Mfg Site)	LinkSymphoKnee	Arthroplasty	3/20/25	K202924	2	Nonconforming Material/Component
96643	Waldemar Link GmbH & Co. KG (Mfg Site)	LinkSymphoKnee	Arthroplasty	3/21/25	K202924	2	Nonconforming Material/Component
96643	Waldemar Link GmbH & Co. KG (Mfg Site)	LinkSymphoKnee	Arthroplasty	3/22/25	K202924	2	Nonconforming Material/Component
96615	Globus Medical, Inc.	MAGEC	Spine	3/23/25	K171791	2	Nonconforming Material/Component
96494	Tornier, Inc	stryker	Shoulder and Elbow	3/24/25	K100562	2	Under Investigation by firm
96493	Zimmer, Inc.	Zimmer Biomet	Arthroplasty	3/25/25	K181171	2	Under Investigation by firm
96493	Zimmer, Inc.	Zimmer Biomet	Arthroplasty	3/26/25	K181171	2	Under Investigation by firm
96493	Zimmer, Inc.	Zimmer Biomet	Arthroplasty	3/27/25	K181171	2	Under Investigation by firm
96493	Zimmer, Inc.	Zimmer Biomet	Arthroplasty	3/28/25	K181171	2	Under Investigation by firm
96493	Zimmer, Inc.	Zimmer Biomet	Arthroplasty	3/29/25	K181171	2	Under Investigation by firm
96555	Stryker GmbH	IMN Instrument System	Trauma	3/30/25		2	Device Design
96555	Stryker GmbH	IMN Instrument System	Trauma	3/31/25		2	Device Design
96606	Conformis Inc.	Cordera Hip System	Arthroplasty	4/1/25	K202484	2	Labeling Change Control
96437	Tornier S.A.S.	Blueprint Mixed Reality system	Shoulder and Elbow	4/2/25	K222510	2	Device Design
96437	Tornier S.A.S.	Blueprint Mixed Reality system	Shoulder and Elbow	4/3/25	K222510	2	Device Design
96437	Tornier S.A.S.	Blueprint Mixed Reality system	Shoulder and Elbow	4/4/25	K222510	2	Device Design
96437	Tornier S.A.S.	Blueprint Mixed Reality system	Shoulder and Elbow	4/5/25	K222510	2	Device Design
96437	Tornier S.A.S.	Blueprint Mixed Reality system	Shoulder and Elbow	4/6/25	K222510	2	Device Design
96437	Tornier S.A.S.	Blueprint Mixed Reality system	Shoulder and Elbow	4/7/25	K222510	2	Device Design
96437	Tornier S.A.S.	Blueprint Mixed Reality system	Shoulder and Elbow	4/8/25	K222510	2	Device Design
96437	Tornier S.A.S.	Blueprint Mixed Reality system	Shoulder and Elbow	4/9/25	K222510	2	Device Design
96437	Tornier S.A.S.	Blueprint Mixed Reality system	Shoulder and Elbow	4/10/25	K222510	2	Device Design
96782	Onkos Surgical, Inc.	SEGMENTAL STEM	Trauma	4/11/25	K161520	2	Packaging change control
96782	Onkos Surgical, Inc.	SEGMENTAL STEM	Trauma	4/12/25		2	Packaging change control
96782	Onkos Surgical, Inc.	SEGMENTAL STEM	Trauma	4/13/25	K161520	2	Packaging change control
96782	Onkos Surgical, Inc.	SEGMENTAL STEM	Trauma	4/14/25	K161520	2	Packaging change control
96782	Onkos Surgical, Inc.	SEGMENTAL STEM	Trauma	4/15/25	K161520	2	Packaging change control
96782	Onkos Surgical, Inc.	SEGMENTAL STEM	Trauma	4/16/25	K203815	2	Packaging change control
96780	Onkos Surgical, Inc.	ELEOS Limb Salvage System	Trauma	4/17/25	K161520	2	Nonconforming Material/Component
96781	Onkos Surgical, Inc.	Limb Salvage System With BioGrip	Trauma	4/18/25	K203815	2	Labeling Change Control
96781	Onkos Surgical, Inc.	Limb Salvage System With BioGrip	Trauma	4/19/25	K203815	2	Labeling Change Control
96586	Smith & Nephew, Inc.	TRIGEN	Trauma	4/20/25	K092748; K210980	2	Process control
96686	Augmedics Ltd.	Augmedics	Spine	4/21/25	K211188	2	Device Design
96632	SCIENCE & BIO MATERIALS	BIO 1 Granules for filling ¿1mm (2cm3)	Trauma; Foot and Ankle	4/22/25	K021963	2	Process control

The Dashboard provides orthopaedic-specific recall information that will ensure the quality of patient care and protect the health and well-being of their patients.

If you have any questions, please contact patientsafety@aaos.org.