Recall Z-2348-2021 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DePuy Orthopaedics, Inc.
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
| Date | Jul 1, 2021 |
| Status | Terminated |
| Reason | Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement |
| Root cause | Process change control |
| Action | DePuy Syntheses issued Medical Device Product Recall (Removal) Ref. 1986537 dated 7/1/21. Letter states reason for recall, health risk and action to take: Please take the Following Steps: 1.Examine your inventory immediately to determine if you have the subject lot and quarantine theproduct. 2.Contact your DePuy Synthes Sales Consultant to coordinate the return of any affected devices or callcustomer service following the typical returns process in order to acquire a return number prior toshipping product. 3.Review, complete, sign, and return the attached business response form (page 3 of th |
| Quantity | 7 units |
| Distribution | International distribution in the countries of Canada, France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160700 | ATTUNE Revision Knee System Depuy(Ireland), Jun 10, 2016 |