BEUDAMED
    FDA Enforcement Class II Ongoing

    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.

    Recall: Z-1343-2026 · Reported February 18, 2026

    Enforcement

    Recall Number
    Z-1343-2026
    Event ID
    98251
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Alphatec Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2026
    Initiation Date
    January 2, 2026
    Classification Date
    February 11, 2026
    Address
    1950 Camino Vida Roble, N/A, Carlsbad, CA, 92008-6505, United States

    Description

    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.

    Reason

    Due a design issue where the navigated array connection geometry is incorrect.

    Code Info

    Model/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693

    Distribution

    U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.

    Quantity

    15 units