Recall Z-1778-2008 ยท HTO Reamer
Stryker Howmedica Osteonics Corp.
Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Howmedica Osteonics Corp., 325 Corporate Drive; Mahwah, NJ 07430 Authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan Cedex, France
| Date | Aug 27, 2008 (initiated Apr 15, 2005) |
| Status | Terminated |
| Reason | The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture. |
| Root cause | Process control |
| Action | An IMPORTANT MARKET WITHDRAWAL letter was issued on April 19, 2005 and sent Federal Express to those consignees who received the device. The letter instructed them to examine their inventory to identify instruments, reconcile these instruments on an attached accountability form; fax a copy of this form within 2 days of receipt of the letter; retrieve and return affected product; contact Stryker Customer Service to re-order. |
| Quantity | 24 total |
| Distribution | Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.