BEUDAMED
    FDA Enforcement Class II Terminated

    Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126

    Recall: Z-0495-2019 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0495-2019
    Event ID
    81472
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 28, 2018
    Initiation Date
    October 22, 2018
    Classification Date
    November 21, 2018
    Termination Date
    December 11, 2019
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126

    Reason

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

    Code Info

    Lot Number: J6255863 UDI: (01)00880304270794(17)280411(10)J6265594

    Distribution

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

    Quantity

    8 units