BEUDAMED
    FDA Recall Terminated

    Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150491. Orthopedic implant intended as part of a replacement knee joint.

    Recall: Z-1880-2008 · Initiated May 15, 2008

    Recall

    Recall Number
    Z-1880-2008
    Event Number
    48633
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KRO
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    May 15, 2008
    Posted
    September 11, 2008
    Terminated
    November 3, 2008
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150491. Orthopedic implant intended as part of a replacement knee joint.

    Reason

    Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package contents.

    Action

    On May 15, 2008 an Urgent Medical Device Removal Notice was issued to consignees and implanting physicians notifying them to return the product and of risks involved, respectively. Any adverse reactions which may be experienced with the use of this product should be reported to FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852, or the MedWatch website at www.fda.gov/medwatch. If you have any questions contact Mary Hardesty, Manager, Corrective Actions, Biomet Orthopedics, Inc. at 1-800-348-9500.

    Distribution

    Class II Recall - Nationwide Distribution --- including states of California, Indiana, Kentucky, Massachusetts and Virginia.

    Quantity

    14 for all products.