Recall Z-1141-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ
| Date | Mar 16, 2010 (initiated Aug 20, 2007) |
| Status | Terminated |
| Reason | A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right. |
| Root cause | Process design |
| Action | Stryker Important Product Removal Letters were sent via Federal Express on 8/20/2007. |
| Quantity | 4 units |
| Distribution | Product went to 2 US Stryker branches. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030978 | SCORPIO NRG KNEE SYSTEM Howmedica Osteonics Corp., Nov 20, 2003 |