Recall Z-1381-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.
| Date | Jul 16, 2008 (initiated Feb 8, 2005) |
| Status | Terminated |
| Reason | Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component. |
| Root cause | Labeling mix-ups |
| Action | Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825. |
| Quantity | 7 units |
| Distribution | Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK. |
| 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 |