BEUDAMED
    FDA Enforcement Class II Ongoing

    Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03

    Recall: Z-0587-2024 · Reported December 27, 2023

    Enforcement

    Recall Number
    Z-0587-2024
    Event ID
    93507
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 27, 2023
    Initiation Date
    November 21, 2023
    Classification Date
    December 19, 2023
    Address
    2320 Nw 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03

    Reason

    Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

    Code Info

    a) 350-21-04, GTIN 10885862276247, Serial Numbers: A644020; b) 350-22-03, GTIN 10885862276353, Serial Numbers: A641653, A641655, A641659, A641660, A641662, A641663, A641666, A641667, A641668, A641669, A641672, A641654

    Distribution

    US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK

    Quantity

    N/A