BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated July 7, 2023

    Recall

    Recall Number
    Z-2475-2023
    Event Number
    92776
    Firm
    Alphatec Spine, Inc. 1950 Camino Vida Roble
    FEI Number
    2027467
    Product Code
    HWJ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 7, 2023
    Posted
    August 28, 2023
    Address
    Carlsbad, CA, 92008-6505

    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.

    Action

    On 7/7/23, recall notices were emailed to consignees who were asked to do the following: 1) Abstain from sale and/or use and return to the recalling firm. 2) Complete and return the response form via email to [email protected] Questions/concerns can be directed to 1-800-922-1356 or [email protected]

    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