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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 Trauma 5/25/22 K040212 2 Under Investigation
89983 restor3d Inc. Non-Sterile Double Ended Trial Kit Foot and Ankle 4/29/22 N/A 2 Process change control
89959 DePuy VELYS™ Robotic-Assisted Solution Arthroplasty 5/2/22 K202769 2 Software design
89903 Conformis, Inc. iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KR Arthroplasty 4/8/22 K210809   2 Nonconforming Material/Component
89868 American Contract Systems Orthopedic Tray Hand 5/6/22 N/A 2 Process 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 N/A 2 Process change control
89671 Stradis Medical Total Knee Pack - Surgical Kit Arthroplasty 4/4/22 N/A 2 Process change control
89619 Zimmer NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE Arthroplasty 3/3/22 K110054 2 Under Investigation by firm
89544 Biomet Arcos Modular Revision Hip System Arthroplasty 2/24/22 N/A 2 Process Control
89507 Wright Medical Technology ORTHOLOC 2.0/2.4 PLATE SYSTEM Trauma; Foot and Ankle 3/15/22 K090692 2 Process Control
89471 ROi CPS Regard, TOTAL HIP - SPRINGFIELD Arthroplasty 2/28/22 N/A 2 Under Investigation by firm
89454 DePuy ATTUNE Revision Knee System Arthroplasty 2/9/22 K160700 2 Nonconforming Material/Component
89428 Synthes Universal Chuck Trauma 2/10/22 N/A 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
89177 Ellipse Technologies ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM Spine 1/26/22 K140178 2 Device Design
89092 Conventus Orthopaedics Flex-ThreadTM Distal Fibula Intramedullary Nail System Foot and Ankle; Trauma 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.