BEUDAMED
    FDA Recall Terminated

    Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery.

    Recall: Z-0181-2009 · Initiated July 28, 2008

    Recall

    Recall Number
    Z-0181-2009
    Event Number
    49464
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 28, 2008
    Posted
    October 24, 2008
    Terminated
    September 22, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery.

    Reason

    The pin and clip may fracture during use.

    Action

    Consignees were notified by recall letter dated 7/28/08 to remove the recalled lots from use and to return them. Contact Biomet, Inc. at 1-800-348-9500 or 1- 574-372-3983 for assistance.

    Distribution

    Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden.

    Quantity

    85