Recall Z-1814-2008 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Stryker Howmedica Osteonics Corp.
Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Code K05L224.
| Date | Sep 11, 2008 (initiated Nov 8, 2005) |
| Status | Terminated |
| Reason | Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa. |
| Root cause | Employee error |
| Action | Consignees were notified by letter sent via Federal Express with return receipt on November 8, 2005. All consginees who received the subject devices were provided Product Accountability forms to be returned to the firm. |
| Quantity | 8 units |
| Distribution | Worldwide Distribution |
| 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 |