BEUDAMED
    FDA Enforcement Class II Terminated

    Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415

    Recall: Z-1812-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1812-2021
    Event ID
    87887
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alphatec Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 16, 2021
    Initiation Date
    April 26, 2021
    Classification Date
    June 7, 2021
    Termination Date
    November 17, 2022
    Address
    1950 Camino Vida Roble, N/A, Carlsbad, CA, 92008-6505, United States

    Description

    Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415

    Reason

    There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.

    Code Info

    8663402R and 8609317R

    Distribution

    US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY.

    Quantity

    14 units