BEUDAMED
    FDA Enforcement Class II Terminated

    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

    Recall: Z-1439-2021 · Reported April 28, 2021

    Enforcement

    Recall Number
    Z-1439-2021
    Event ID
    87626
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 28, 2021
    Initiation Date
    March 17, 2021
    Classification Date
    April 20, 2021
    Termination Date
    May 3, 2023
    Address
    4340 Swinnea Rd, N/A, Memphis, TN, 38118-6603, United States

    Description

    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

    Reason

    The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

    Code Info

    GTIN 00191375013006, Lot Number TM0126527

    Distribution

    US Nationwide distribution.

    Quantity

    11 devices