BEUDAMED
    FDA Enforcement Class II Ongoing

    LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,

    Recall: Z-2475-2023 · Reported September 6, 2023

    Enforcement

    Recall Number
    Z-2475-2023
    Event ID
    92776
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Alphatec Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 6, 2023
    Initiation Date
    July 7, 2023
    Classification Date
    August 28, 2023
    Address
    1950 Camino Vida Roble, N/A, Carlsbad, CA, 92008-6505, United States

    Description

    LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,

    Reason

    Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.

    Code Info

    UDI-DI: 00190376228037, Lot: EM50715

    Distribution

    US Nationwide distribution in the states of CT, IN, TX, LA, OH, AL, NH, MA, NC, AZ, MD, NJ, IL, CA, UT, MI.

    Quantity

    29