BEUDAMED
    FDA Enforcement Class II Completed

    INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

    Recall: Z-1753-2024 · Reported May 8, 2024

    Enforcement

    Recall Number
    Z-1753-2024
    Event ID
    94337
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Innomed, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 8, 2024
    Initiation Date
    March 7, 2024
    Classification Date
    May 1, 2024
    Address
    103 Estus Dr, Savannah, GA, 31404-1445, United States

    Description

    INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

    Reason

    54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.

    Code Info

    UDI/DI 00840277104007, Lot Number 1223K

    Distribution

    FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada

    Quantity

    41 devices