BEUDAMED
    FDA Enforcement Class II Ongoing

    Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045

    Recall: Z-0125-2025 · Reported October 23, 2024

    Enforcement

    Recall Number
    Z-0125-2025
    Event ID
    95395
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    XTANT Medical Holdings, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2024
    Initiation Date
    August 21, 2024
    Classification Date
    October 17, 2024
    Address
    664 Cruiser Ln, Belgrade, MT, 59714-9719, United States

    Description

    Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045

    Reason

    Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.

    Code Info

    UDI-DI: 00810076563190, Lot: DNI

    Distribution

    US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.

    Quantity

    330