BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0125-2025 · Initiated August 21, 2024

    Recall

    Recall Number
    Z-0125-2025
    Event Number
    95395
    Firm
    XTANT Medical Holdings, Inc
    FEI Number
    3005031160
    Product Code
    NKB
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    August 21, 2024
    Posted
    October 17, 2024
    Address
    664 Cruiser Ln, Belgrade, MT, 59714-9719

    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.

    Action

    On 8/21/24, recall notices were mailed and emailed to customers who were asked to do the following: 1) Examine affected devices and quarantine any screws with DNI markings. 2) Notify your staff about the recall. If affected devices were further distributed, provide the recall notice to these customers. 3) Complete and return the response forms via email to [email protected]

    Distribution

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

    Quantity

    330