BEUDAMED
    FDA Recall Terminated

    Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics, Inc., Warsaw, IN. A knee prosthesis intended for single use implantation to replace the articular portions of the knee joint.

    Recall: Z-0289-2009 · Initiated September 22, 2008

    Recall

    Recall Number
    Z-0289-2009
    Event Number
    49867
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 22, 2008
    Posted
    November 21, 2008
    Terminated
    September 22, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics, Inc., Warsaw, IN. A knee prosthesis intended for single use implantation to replace the articular portions of the knee joint.

    Reason

    The package is properly labeled, but the laser etch for size incorrectly reads "16 X 63/63" instead of the correct size, "16 X 63/67".

    Action

    A notification letter (Urgent Medical Device Removal Notice) dated 9/22/08 was sent to the firm's sales staff with instructions to locate and retrieve the product and to notify customers at affected hospitals of the problem. Questions related to this notice should be directed to the Biomet Orthopedics, LLC Corrective Actions Manager at 800-348-9500 or 574-372-3983, Monday through Friday, 8 A.M. to 5 P.M. (EST).

    Distribution

    Worldwide Distribution: USA including states of Florida, New Jersey, Maryland, Pennsylvania, South Carolina, South Dakota, and Virginia, and country of Finland.

    Quantity

    11