Recall Z-1593-2010 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Accolade Distal Centralizer 14 mm Large; Catalog No.: 1059-6714. For use with Accolade hip prosthesis.
| Date | May 12, 2010 (initiated Mar 31, 2010) |
| Status | Terminated |
| Reason | One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have been labeled as size 14 Large centraliizers. |
| Root cause | Process control |
| Action | Notification letters and Product Accountability Forms have been sent to Stryker Orthopaedics Branch and Agencies via Fed Ex on March 31, 2010 with return receipt.. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons were sent notificatio letters and Product Recall Acknowledgment Forms on April 1, 2010. with return reciept. |
| Quantity | 17 |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974054 | DISTAL CENTRALIZER, EXETER II HIP SYSTEM Howmedica, Inc., Dec 23, 1997 |