BEUDAMED
    FDA Recall Terminated

    Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141232, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.

    Recall: Z-2140-2011 · Initiated March 3, 2011

    Recall

    Recall Number
    Z-2140-2011
    Event Number
    58342
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 3, 2011
    Posted
    April 28, 2011
    Terminated
    July 27, 2011
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141232, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prostheses intended for application with or without bone cement.

    Reason

    The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".

    Action

    Biomet Orthopedics Inc initiated an electronic communication with Direct Accounts on March 3, 2011 and instructed them to quarantine and return all remaining/unused devices to the firm. For questions regarding this recall call 574-372-3983.

    Distribution

    Worldwide Distribution -USA including FL, IN, and NC and the countries of Japan and the Netherlands

    Quantity

    8