BEUDAMED
    FDA Recall Terminated

    Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet Orthopedics, Inc., Warsaw, IN 46581

    Recall: Z-0123-2008 · Initiated August 31, 2007

    Recall

    Recall Number
    Z-0123-2008
    Event Number
    44814
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 31, 2007
    Posted
    December 5, 2007
    Terminated
    June 4, 2008
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet Orthopedics, Inc., Warsaw, IN 46581

    Reason

    Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

    Action

    Biomet notified consignees via letter dated 8/31/07, titled Urgent Medical Device Recall Notice to immediately discontinue use of the product and to return units to Biomet.

    Distribution

    Nationwide.

    Quantity

    16