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Terminated

Depuy brand LCS Complete metal backed patella, cemented, STD; REF 1294-09-740.

FDA Recall Z-1028-05 · Posted 2005-07-21

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeNJL
Date Initiated2005-06-07
Date Terminated2006-05-02

Reason for Recall

There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.

Firm Action

Hospitals were notified via letter dated June 10, 2005 requesting that they quarantine product on hand and send in a response card to the firm.

Root Cause

Other

Distribution Pattern

Nationwide and international.

Official Source

View FDA Recall →

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

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