BEUDAMED
    FDA Recall Terminated

    Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm right stem, Sterile, REF 11-104953, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery.

    Recall: Z-1672-2010 · Initiated March 10, 2010

    Recall

    Recall Number
    Z-1672-2010
    Event Number
    55365
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    March 10, 2010
    Posted
    May 26, 2010
    Terminated
    October 18, 2010
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm right stem, Sterile, REF 11-104953, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery.

    Reason

    The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep.

    Action

    Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 10, 2010. The letter went to distributors and users of the recalled device. The letter instructed the consignees to locate the recalled product and return the product to the firm. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8:00 AM to 5:00 PM.

    Distribution

    Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.

    Quantity

    6