BEUDAMED
    FDA Recall Terminated

    Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38)

    Recall: Z-1151-2007 · Initiated June 14, 2007

    Recall

    Recall Number
    Z-1151-2007
    Event Number
    38121
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 14, 2007
    Posted
    August 7, 2007
    Terminated
    December 12, 2007
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38)

    Reason

    The instrument was manufactured incorrectly and use could result in the instrument binding to the acetabular component and cause implant to not release following inpaction.

    Action

    On 6/13/07, the firm sent a Urgent Medica Device Correction Notice to its sales force instructing them to retrieve affected units from their hospital accounts and to return them to the firm. International accounts were notified via email on 6/14/07.

    Distribution

    World wide: USA, Australia, and Finland.

    Quantity

    94