Recall Z-0795-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics. Intended for cemented application to replace the articulating surface of the distal femur.
| Date | Feb 19, 2010 (initiated Jul 30, 2007) |
| Status | Terminated |
| Reason | Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT. |
| Root cause | Labeling mix-ups |
| Action | Stryker Orthopaedics issued an "Important Product Removal" letter via Federal Express dated July 30, 2007 to all direct accounts. Users were asked to identify and return all affected product to the firm. For further information, contact Stryker Orthopaedics at (201) 831-5825. |
| Quantity | 7 |
| Distribution | Worldwide Distribution -- United States and France. |
| 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 |