BEUDAMED
    FDA Recall Terminated

    Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck,1 Taper, Sterile, Biomet Orthopedics, Warsaw, IN Product Usage: Intended for use in non-cemented primary and revision hip joint replacement

    Recall: Z-1449-2012 · Initiated September 13, 2011

    Recall

    Recall Number
    Z-1449-2012
    Event Number
    60595
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 13, 2011
    Posted
    April 23, 2012
    Terminated
    February 21, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck,1 Taper, Sterile, Biomet Orthopedics, Warsaw, IN Product Usage: Intended for use in non-cemented primary and revision hip joint replacement

    Reason

    Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.

    Action

    Biomet contacted consignees with device inventory by telephone on September 13, 2011 requesting all associated product be quarantined immediately. An Urgent Medical Device Recall Notice was sent via U.S. mail March 23, 2012 to consignees with directions to immediately locate, discontinue use of the affected product and return to Biomet. The letter instructed consignees to carefully follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. The notification letter to consignees contained directions to confirm receipt of notice by calling 800-348-9500, extension 3983 or 3009. Questions concerning recall are directed to 574-372-3983 or 574371-3009 M-F 8 A.M. to 5 P.M. (ET).

    Distribution

    USA Nationwide Distribution including the states of: MI, NC., OK and WI.

    Quantity

    5 devices