BEUDAMED
    FDA Recall Terminated

    Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472088. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.

    Recall: Z-1528-2009 · Initiated May 19, 2009

    Recall

    Recall Number
    Z-1528-2009
    Event Number
    51980
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KRO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 19, 2009
    Posted
    June 29, 2009
    Terminated
    October 8, 2010
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472088. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.

    Reason

    The retaining ring may fall out of the instrument during surgery.

    Action

    Distributors and consignees were notified by an Urgent Medical Device Recall Notice dated 5/19/09. Distributors and consignees were instructed to locate and remove the devices from circulation, carefully follow the instructions on the "FAX Back Response Form," and fax a copy of the Response Form to 574-372-1683 prior to return of the product. If the product has been further distributed, consignees must notify hospital personnel responsible for receiving recall notices of the action, via the enclosed "Dear Biomet Customer" notice. Consignees are responsible for the location and return of products to the firm. The letter stated that the instruments would be reworked and returned.

    Distribution

    Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.

    Quantity

    387 of all products