Stryker Orthopaedics, Accolade Distal Centralizer 13 mm Medium; Catalog No.: 1059-4513. For use with Accolade hip prosthesis.
FDA Recall Z-1594-2010 · Posted 2010-05-12
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJDI
Date Initiated2010-03-31
Date Terminated2010-07-09
Product Quantity15
Reason for Recall
One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have been labeled as size 14 Large centraliizers.
Firm Action
Notification letters and Product Accountability Forms have been sent to Stryker Orthopaedics Branch and Agencies via Fed Ex on March 31, 2010 with return receipt.. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons were sent notificatio letters and Product Recall Acknowledgment Forms on April 1, 2010. with return reciept.
Root Cause
Process control
Distribution Pattern
Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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