BEUDAMED
    FDA Recall Terminated

    Depuy brand LCS Complete metal backed patella, cemented, STD+; REF 1294-09-750.

    Recall: Z-1029-05 · Initiated June 7, 2005

    Recall

    Recall Number
    Z-1029-05
    Event Number
    32282
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    NJL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2005
    Posted
    July 21, 2005
    Terminated
    May 2, 2006
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Depuy brand LCS Complete metal backed patella, cemented, STD+; REF 1294-09-750.

    Reason

    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.

    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.

    Distribution

    Nationwide and international.