BEUDAMED
    FDA Recall Open, Classified

    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000

    Recall: Z-2598-2023 · Initiated August 7, 2023

    Recall

    Recall Number
    Z-2598-2023
    Event Number
    92841
    Firm
    Stryker Corporation
    FEI Number
    3015967359
    Product Code
    LZN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 7, 2023
    Posted
    September 19, 2023
    Address
    1941 Stryker Way, Portage, MI, 49002-9711

    Description

    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000

    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

    Action

    Stryker issued Urgent Medical Device Recall letter on 8/07/23. Letter states reason for recall, health risk and action to take: Actions needed 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if affected product is no longer in inventory, to the email [email protected]. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement order will be shipped to customers upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. If you have any questions about this matter, contact Stryker Instruments by email at [email protected].

    Distribution

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

    Quantity

    5155 units US; 1607 units OUS