BEUDAMED
    FDA Enforcement Class II Ongoing

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    Recall: Z-1573-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1573-2022
    Event ID
    90603
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mizuho OSI
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2022
    Initiation Date
    July 29, 2021
    Classification Date
    August 24, 2022
    Address
    30031 Ahern Ave, Union City, CA, 94587-1234, United States

    Description

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    Reason

    One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.

    Code Info

    Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712

    Distribution

    U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada

    Quantity

    13 devices