Recall Z-0058-06 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
| Date | Oct 15, 2005 (initiated Aug 11, 2005) |
| Status | Terminated |
| Reason | The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa. |
| Root cause | Other |
| Action | The recall notification was sent out via FedEx on 8/11/2005 with requested return receipt. |
| Quantity | 8 units |
| Distribution | The product was distributed to their sales representatives/sales agencies, hospitals, and international distribution. The product was shipped to Stryker Germany and Stryker France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974556 | OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM Osteonics Corp., Feb 27, 1998 |