BEUDAMED
    FDA Enforcement Class II Terminated

    Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty

    Recall: Z-3250-2018 · Reported October 3, 2018

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    Enforcement

    Recall Number
    Z-3250-2018
    Event ID
    80904
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2018
    Initiation Date
    August 2, 2018
    Classification Date
    September 25, 2018
    Termination Date
    April 25, 2019
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty

    Reason

    The implant only has one bolt in the sterile package but it should have had two.

    Code Info

    Lot 585070, UDI (01) 0088030448157 (17) 230215 (10) 585070

    Distribution

    Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.

    Quantity

    16