BEUDAMED
    FDA Enforcement Class II Terminated

    X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.

    Recall: Z-0533-2022 · Reported February 9, 2022

    Enforcement

    Recall Number
    Z-0533-2022
    Event ID
    89367
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    XTANT Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 9, 2022
    Initiation Date
    December 29, 2021
    Classification Date
    January 28, 2022
    Termination Date
    June 17, 2024
    Address
    664 Cruiser Ln, N/A, Belgrade, MT, 59714-9719, United States

    Description

    X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.

    Reason

    The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.

    Code Info

    X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963

    Distribution

    U.S.: CA, MI, NV, and TX O.U.S.: Portugal

    Quantity

    24 devices