BEUDAMED
    FDA Recall Terminated

    Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108

    Recall: Z-0496-2019 · Initiated October 22, 2018

    Recall

    Recall Number
    Z-0496-2019
    Event Number
    81472
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    October 22, 2018
    Terminated
    December 11, 2019
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108

    Reason

    Label on the outer carton or the patient labels does not match label on the inner sterile packaging

    Action

    Zimmer issued recall letter on 10/22/18 via email and FedEx. Acountts requested to immediately locate and quarantine affected product in your inventory. Return affected product from your distributorship and from affected hospitals. Complete Inventory Return Certification Form. uestions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

    Distribution

    AR, MO, MN, NJ, NY, OH, MN , NJ, VA

    Quantity

    8 units