BEUDAMED
    FDA Recall Terminated

    Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet Orthopedics, Inc., Warsaw, IN.

    Recall: Z-0702-2008 · Initiated October 18, 2007

    Recall

    Recall Number
    Z-0702-2008
    Event Number
    45987
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 18, 2007
    Posted
    February 5, 2008
    Terminated
    March 11, 2008
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet Orthopedics, Inc., Warsaw, IN.

    Reason

    The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component.

    Action

    Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.

    Distribution

    Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

    Quantity

    141 total for all recalls Z-0700-0705-2008