BEUDAMED
    FDA Recall Terminated

    Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.

    Recall: Z-1448-04 · Initiated August 3, 2004

    Recall

    Recall Number
    Z-1448-04
    Event Number
    29832
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    KRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 3, 2004
    Posted
    September 14, 2004
    Terminated
    September 13, 2004
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.

    Reason

    The polyethylene tibial bushing was omitted from the taper of the tibial plates.

    Action

    Consignees were notified via recall letter dated August 3, 2004 and sent via certified mail, return receipt requested. A dear doctor letter dated August 25, 2004 was sent to the implanting physicians.

    Distribution

    Nationwide (California, Florida, Illinois, Indiana, Louisiana, Michigan, Nevada, New Jersey, New York, North Carolina, Ohio, Texas, Wisconsin), and Germany.