BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000

    Recall: Z-2600-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2600-2023
    Event ID
    92841
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 27, 2023
    Initiation Date
    August 7, 2023
    Classification Date
    September 18, 2023
    Address
    1941 Stryker Way, Portage, MI, 49002-9711, United States

    Description

    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000

    Reason

    Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site

    Code Info

    GTIN: 04546540055415 Lot Numbers: 22313012 22314012 22315012 22343012 22348012 22349012 22350012 22353012

    Distribution

    Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK

    Quantity

    652 units US; 1607 units OUS