Recall Z-1601-2010 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Stryker Howmedica Osteonics Corp.
Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. Intended to be used to centralize the femoral stem within the intramedullary canal. intended to be used with bone cement.
| Date | May 13, 2010 (initiated Mar 29, 2010) |
| Status | Terminated |
| Reason | Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label. |
| Root cause | Error in labeling |
| Action | Urgent Product Recall letters and Product Accountability Forms have been sent via Fed Ex on March 29, 2010 with return receipt. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeon were also sent Notification letters and Product Recall Acknowledgment Form on March 29, 2010 with return receipt. The letters explained the issue, the potential hazards, and risk mitigation. The firm asked customers to examine their inventory and hospital locations to identify the affected products. All affected product should be retrieved and returned to their branch or agency warehouse for reco |
| Quantity | 24 units |
| Distribution | Nationwide Distribution -- FL, MN, & OR. |
| 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 |