Recall Z-1241-2007 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325
| Date | Sep 21, 2007 (initiated Oct 17, 2006) |
| Status | Terminated |
| Reason | Loose fixation pegs: One lot of femoral components may have loose fixation pegs. |
| Root cause | Other |
| Action | Notification letters, dated 10/17/2006, were sent via Federal Express on 10/17/2006 to all consignees requesting return of product. |
| Quantity | 3 total, 2 in USA |
| Distribution | Worldwide : One Hospital in Georgia (USA), Stryker Branch in Indiana and Stryker Branch in Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920034 | DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC Pfizer Hospital Products Group, Inc., Mar 18, 1992 |