BEUDAMED
    FDA Enforcement Class II Ongoing

    Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.

    Recall: Z-1488-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1488-2025
    Event ID
    96349
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Spine
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 9, 2025
    Initiation Date
    February 28, 2025
    Classification Date
    March 31, 2025
    Address
    59 State Rt 17 S, Allendale, NJ, 07401-1614, United States

    Description

    Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.

    Reason

    Potential for the gold unlock button to separate from the inserter.

    Code Info

    Catalog 48019100; UDI-DI: 07613327456462; Lot Number: 231634;

    Distribution

    Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.

    Quantity

    64 units (60 US, 4 OUS)