BEUDAMED
    FDA Enforcement Class II Ongoing

    The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.

    Recall: Z-2926-2020 · Reported September 9, 2020

    Enforcement

    Recall Number
    Z-2926-2020
    Event ID
    86261
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2020
    Initiation Date
    August 10, 2020
    Classification Date
    August 31, 2020
    Address
    2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.

    Reason

    The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.

    Code Info

    Catalog Number: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673,6488674,6488675.

    Distribution

    Domestic: CO,FL,OK, PA. International: Chile

    Quantity

    11 units