Recall Z-2079-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.
| Date | Sep 16, 2008 (initiated Mar 17, 2005) |
| Status | Terminated |
| Reason | Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component. |
| Root cause | Process control |
| Action | The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005 |
| Quantity | 1 unit |
| Distribution | The one unit was distributed to an International Stryker branch. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962152 | OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM Osteonics Corp., Aug 14, 1996 |