BEUDAMED
    FDA Recall Terminated

    Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Biomet Orthopedic, Inc.

    Recall: Z-0076-2008 · Initiated July 24, 2007

    Recall

    Recall Number
    Z-0076-2008
    Event Number
    44825
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 24, 2007
    Posted
    October 31, 2007
    Terminated
    July 24, 2008
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Biomet Orthopedic, Inc.

    Reason

    Incorrect Product -- Mislabeled as to size; a 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.

    Action

    The firm notified distributor by phone on or about 7/24/07 and followed up with an Urgent Medical Device Recall Notice/Letter dated 8/31/07. The letter requested that the product be discontinued and returned to Biomet.

    Distribution

    Class II Recall - Worldwide Distribution --- USA including states of IA, SD, and countries of Brazil and Chile.

    Quantity

    4