BEUDAMED
    FDA Recall Terminated

    Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.

    Recall: Z-2042-2009 · Initiated August 6, 2009

    Recall

    Recall Number
    Z-2042-2009
    Event Number
    52885
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 6, 2009
    Posted
    September 8, 2009
    Terminated
    October 6, 2010
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618.

    Reason

    These surgical instruments are etched with incorrect measurement markings.

    Action

    Consignees were notified by letter dated 8/6/09 to remove the instrument from use and to return the recalled instrument to Biomet. Implanting surgeons were notified by letter dated 8/6/09, advised of the problem and it was suggested that the patients be monitored for instability if deemed necessary by the surgeon.

    Distribution

    Nationwide Distribution -- Including the state of Texas.

    Quantity

    2