BEUDAMED
    FDA Recall Terminated

    P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703

    Recall: Z-1369-04 · Initiated December 22, 2003

    Recall

    Recall Number
    Z-1369-04
    Event Number
    29314
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 22, 2003
    Posted
    August 24, 2004
    Terminated
    September 23, 2004
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703

    Reason

    The collar was incorrectly etched for the R (right) and L (Left) orientation

    Action

    Depuy notified distributors at the various territories via verbal contact on 12/23/2003

    Distribution

    NY

    Quantity

    1 unit