BEUDAMED
    FDA Recall Terminated

    Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number: RD115112. A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint.

    Recall: Z-1614-2009 · Initiated March 16, 2009

    Recall

    Recall Number
    Z-1614-2009
    Event Number
    52092
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 16, 2009
    Posted
    July 14, 2009
    Terminated
    October 6, 2010
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number: RD115112. A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint.

    Reason

    The firm has received reports of fractured heads, requiring revision surgery.

    Action

    Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 16, 2009 to users describing the affected device. Consignees were instructed to locate and discontinue use of the product and quarantine until a sales representative can arrange for removal. Consignees were also asked to complete and return the attached "Fax-Back Response Form" to Biomet at 1-574-372-1683. Further questions can be directed to Biomet Orthopedics at 1-800-348-9500.

    Distribution

    Worldwide Distribution -- US including PR and states of AZ, AL, AR, CA, CO, FL, IL, IN, KY, KS, MA, MI, LA, NY, SD, GA, MN, PA, NJ, MD, MI, OH, ME, TX, WA, WI and VA and countries of Australia, Belgium, Canada, Costa Rica, Finland, Netherlands and South Wales.

    Quantity

    161