BEUDAMED
    FDA Recall Terminated

    Biomet Vanguard microplasty slidex femoral 4-in-1 block, 62.5 mm, stainless steel; Ref. 32-485103.

    Recall: Z-1447-05 · Initiated May 16, 2005

    Recall

    Recall Number
    Z-1447-05
    Event Number
    32124
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HTZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 16, 2005
    Posted
    August 31, 2005
    Terminated
    September 8, 2005
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Biomet Vanguard microplasty slidex femoral 4-in-1 block, 62.5 mm, stainless steel; Ref. 32-485103.

    Reason

    The instrument may have been assembled improperly, which may result in reversed resection cuts on the femur and affect implant performance, resulting in the need for revision surgery.

    Action

    Biomet distributors were issued a letter dated 5/16/05 instructing them to locate the instruments and conduct a field inspection of the instruments to verify the pin location offset and ensure the correct orientation of the anterior marking on the slide component.

    Distribution

    Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Denmark, Finland, Greece, Israel, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, and the United Kingdom.

    Quantity

    456