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's Reason for Recall
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
89983	restor3d Inc.	Non-Sterile Double Ended Trial Kit	Spine	4/29/22	N/A	2	Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
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
89868	American Contract Systems	Orthopedic Tray	Hand	5/6/22	N/A	2	Product was sterilized with a higher than specification EO concentration.
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	N/A	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	N/A	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.
89544	Biomet	Arcos Modular Revision Hip System	Arthroplasty	2/24/22	N/A	2	The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
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.
89428	Synthes	Universal Chuck	Trauma	2/10/22	N/A	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.
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
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.
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
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.
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.
90074	Medacta Usa Inc	GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1	Arthroplasty	06/07/22		2	A Size 2 trial baseplate was assembled with Size 1 instrument sets.
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.
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.
90216	Wright Medical Technology, Inc.	INFINITY TOTAL ANKLE SYSTEM	Foot and Ankle	06/27/22	K140749	2	The instrument is incorrectly color coded.
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.
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.
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
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
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
90436	Paragon 28, Inc.	HammerTube Implant	Foot and Ankle	07/27/22	K171715	2	Due to Titanium plasma coating not present 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.
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.
90502	Aesculap Implant Systems LLC	S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM	Spine	07/21/22	K062012	2	Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
90526	Aesculap Implant Systems LLC	ENNOVATE MIS REMOVALKEY SHORT,	Spine	07/21/22		2	Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.
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.
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
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.
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.
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.
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
90753	Paragon 28, Inc.	Grappler Suture Anchor System	Foot and Ankle	09/22/22	K211002	2	Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
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.
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.
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.
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).
90996	Acumed LLC	Acutrak and Mini Acutrak Fixation Screws	Hand; Foot and Ankle; Trauma	12/23/22	K221333	2	Distribution without Pre-Market Clearance
91016	Novapproach Spine LLC	OneLIF Intervertebral Body Replacement System	Spine	11/17/22	K211769	2	The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.
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)
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.
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.
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.
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.
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.
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.
91143	Arthrex, Inc.	Arthrex Osteochondral Autograft Transplantation	Sports	12/08/22		2	The devices may be packaged with the wrong reamer size.
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.
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

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.