BEUDAMED
    FDA Recall Terminated

    Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 10mm Lft.

    Recall: Z-0853-03 · Initiated January 23, 2003

    Recall

    Recall Number
    Z-0853-03
    Event Number
    25640
    Firm
    Stryker Howmedica Osteonics
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 23, 2003
    Posted
    May 21, 2003
    Terminated
    December 1, 2004
    Address
    300 Commerce Court, Mahwah, NJ, 07430

    Description

    Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 10mm Lft.

    Reason

    The device is demonstrating early wear and delamination.

    Action

    Recall letters were sent to the Howmedica branches and hospitals on January 23, 2003 via FedEx.

    Distribution

    Howmedica distributed this device to 2 Howmedica branches and 3 hospitals are Parkview Episcopal Hospital, Pueblo, CO; St. Mary Corwin Hospital, Pueblo, CO; and Hement Valley Hospital, Riverside, CA.

    Quantity

    1