Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Howmedica Osteonics Corp., 325 Corporate Drive; Mahwah, NJ
FDA device recall Z-1778-2008 · posted 2008-08-27 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HTO
- Quantity affected
- 24 total
- Distribution
- Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom.
- Date initiated
- 2005-04-15
- Date posted
- 2008-08-27
- Date terminated
- 2008-09-24
- Location
- Mahwah, NJ
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