BEUDAMED
    FDA Recall Terminated

    Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.

    Recall: Z-2945-2011 · Initiated July 6, 2011

    Recall

    Recall Number
    Z-2945-2011
    Event Number
    59058
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 6, 2011
    Posted
    August 4, 2011
    Terminated
    September 26, 2012
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.

    Reason

    The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.

    Action

    Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to quarantine and return the devices, and a return form. For information or questions on this recall call Biomet at (574) 371-3756.

    Distribution

    Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands.

    Quantity

    8