BEUDAMED
    FDA Recall Terminated

    OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used to replace the tibial portion of the knee joint.

    Recall: Z-2213-2008 · Initiated November 7, 2007

    Recall

    Recall Number
    Z-2213-2008
    Event Number
    45806
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KRO
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 7, 2007
    Posted
    September 17, 2008
    Terminated
    March 13, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used to replace the tibial portion of the knee joint.

    Reason

    Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.

    Action

    Consignees were notified by an Urgent Medical Device Recall Notice letter dated 11/7/07. The letter required that use of the product be immediately discontinued and that components be returned to Biomet. Letters to hospital administrators and the five implanting surgeons were issued on/or about 5/6/08 advising them of the problem and to perform patient evaluations.

    Distribution

    Nationwide Distribution --- including states of California, Florida, Illinois, Indiana, Massachusetts, Missouri, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington.

    Quantity

    22