BEUDAMED
    FDA Recall Terminated

    Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581

    Recall: Z-0102-2008 · Initiated August 9, 2007

    Recall

    Recall Number
    Z-0102-2008
    Event Number
    44812
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 9, 2007
    Posted
    October 27, 2007
    Terminated
    June 26, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581

    Reason

    Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.

    Action

    The distributor was notified via phone on or about 8/9/07 and by letter dated 8/31/07 and requested to return the product. Returns included subaccounts

    Distribution

    Nationwide

    Quantity

    5