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.
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.
|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|
|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.