BEUDAMED
    FDA Recall Terminated

    Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery; impactor.

    Recall: Z-0646-2010 · Initiated December 1, 2009

    Recall

    Recall Number
    Z-0646-2010
    Event Number
    53945
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 1, 2009
    Posted
    January 15, 2010
    Terminated
    October 18, 2010
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery; impactor.

    Reason

    The locking hook tabs may fracture and fragments remain in the patient post-operatively.

    Action

    Urgent Medical Device Recall Notices were sent to distributors on 12/01/2009 with a notice for them to provide to medical facilities where distributor-owned inventory is stored. Distributors were instructed to immediately locate and remove the instruments from circulation; follow the instructions on the "FAX Back Response Form" and fax a copy back prior to returning the product; and to return the product to the firm. Questions should be directed to 800-348-9500.

    Distribution

    Worldwide Distribution -- USA, Canada, China, Costa Rica, Denmark, Germany, Netherlands, New Zealand, and United Kingdom.

    Quantity

    92