Device Recall Dashboard

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 Recalls 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 IDManufacturer NameProduct NameSpecialtyRecall DateFDA Device NumberRecall ClassManufacturer Reason
90118 Smith & Nephew, Inc. TRIGEN INTERTAN General 5/25/22 K040212 2 Under Investigation
90047 Johnson & Johnson VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) General 5/18/22 K964982 2 Device Design
89868 American Contract Systems Orthopedic Tray Arthroscopy (Knee & Hand) 5/6/22 N/A 2 Process control
89959 DePuy VELYS™ Robotic-Assisted Solution Joint; Spine 5/2/22 K202769 2 Software design
89983 restor3d Inc. Non-Sterile Double Ended Trial Kit General 4/29/22 N/A 2 Process change control
89764 Nextremity Solutions FLEXFUSION (TM) FIXATION IMPLANT General 4/12/22 K110445 2 Nonconforming Material/Component
89903 Conformis, Inc. iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KR Knee 4/8/22 K210809   2 Nonconforming Material/Component
89738 Siemens Medical Solutions YSIO X.pree General 4/5/22 K201670   2 Software Design
89672 Stradis Medical Anterior Hip Pack - Surgical Kit Hip; Knee 4/4/22 N/A 2 Process change control
89671 Stradis Medical Total Knee Pack - Surgical Kit Knee 4/4/22 N/A 2 Process change control
89507 Wright Medical Technology ORTHOLOC 2.0/2.4 PLATE SYSTEM General 3/15/22 K090692 2 Process Control
89362 Ortho-Clinical Diagnostics VITROS Chemistry Products VersaTips General 3/8/22 N/A 2 Nonconforming Material/Component
89619 Zimmer NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE Knee 3/3/22 K110054 2 Under Investigation by firm
89471 ROi CPS Regard, TOTAL HIP - SPRINGFIELD Hip 2/28/22 N/A 2 Under Investigation by firm
89544 Biomet Arcos Modular Revision Hip System Shoulder 2/24/22 N/A 2 Process Control
89428 Synthes Universal Chuck Knee;Hip 2/10/22 N/A 2 Device Design
89454 DePuy ATTUNE Revision Knee System Knee 2/9/22 K160700 2 Nonconforming Material/Component
89471 ROi CPS Regard, TOTAL HIP - SPRINGFIELD Hip 2/28/22 N/A 2 Under Investigation by firm
89428 Synthes Universal Chuck Knee;Hip 2/10/22 N/A 2 Device Design
89454 DePuy ATTUNE Revision Knee System Knee 2/9/22 K160700   2 Nonconforming Material/Component
89376 ONI, Inc. ORTHONE General 2/9/22 K001773 2 Process Control
89177 Ellipse Technologies ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM Spine 1/26/22 K140178 2 Device Design
89183 Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack General 1/18/22 N/A 2 Under Investivation by Firm
89240 DePuy DEPUY GLOBAL UNITE SHOULDER SYSTEM GLOBAL UNITE Platform Shoulder System Shoulder 1/11/22 K101996; K170748 2 Equipment Maintenance
89092 Conventus Orthopaedics Flex-ThreadTM Distal Fibula Intramedullary Nail System Knee; Ankle 1/3/22 K202858 2 Device Design

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.