Recall Z-0556-05 ยท NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
The Triathlon Posteriorly Stabilized Femoral Component.
| Date | Feb 24, 2005 (initiated Oct 27, 2004) |
| Status | Terminated |
| Reason | The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal. |
| Root cause | Other |
| Action | Notification letters and Product Accountability Froms have been sent via Fedex on 10/27/2004 with return receipt. |
| Quantity | 386 UNITS |
| Distribution | The product is distributed to its branches/agencies and to hospitals nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.