Recall Z-0632-2022 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DePuy Orthopaedics, Inc.
ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
| Date | Jan 5, 2022 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | DePuy Synthesis issued Urgent Medical Device Recall Letter dated 1/5/22. Letter states reason for recall, health risk and action to take: 1. Carefully review the information contained in this notice. 2. Return the subject products using the normal returns process. Work with your sales consultant to ensure that the products are returned and to arrange for a replacement. To receive replacement product or reimbursement, customers must return the products subject to this notice. 3. Complete all fields of the attached Business Response Form. Please make sure to include your facility name and addres |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160700 | ATTUNE Revision Knee System Depuy(Ireland), Jun 10, 2016 |