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Terminated

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

FDA Recall Z-1778-2008 · Posted 2008-08-27

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHTO
Date Initiated2005-04-15
Date Terminated2008-09-24
Product Quantity24 total

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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