BEUDAMED
    FDA Enforcement Class II Ongoing

    Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.

    Recall: Z-0846-2024 · Reported February 7, 2024

    Enforcement

    Recall Number
    Z-0846-2024
    Event ID
    93738
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    XTANT Medical Holdings, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2024
    Initiation Date
    November 28, 2023
    Classification Date
    January 29, 2024
    Address
    664 Cruiser Ln, Belgrade, MT, 59714-9719, United States

    Description

    Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.

    Reason

    Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.

    Code Info

    UDI-DI: 00810076564005, Lot: AP23000143

    Distribution

    US distribution in MI.

    Quantity

    6