BEUDAMED
    FDA Enforcement Class II Terminated

    Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc disease, B. Spondylolisthesis, C. Trauma, D. Spinal Stenosis, E. Deformities, F. Tumor, G. Pseudoarthrosis, and H. Revision of previous surgery. The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy and nitinol components. The system is attached to the anterior aspect of the vertebral body by means of screw to to the cervical spine.

    Recall: Z-1089-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1089-2014
    Event ID
    66660
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthofix, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2014
    Initiation Date
    October 29, 2013
    Classification Date
    February 25, 2014
    Termination Date
    December 9, 2014
    Address
    3451 Plano Pkwy, Lewisville, TX, 75056-9453, United States

    Description

    Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc disease, B. Spondylolisthesis, C. Trauma, D. Spinal Stenosis, E. Deformities, F. Tumor, G. Pseudoarthrosis, and H. Revision of previous surgery. The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy and nitinol components. The system is attached to the anterior aspect of the vertebral body by means of screw to to the cervical spine.

    Reason

    There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.

    Code Info

    86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx All lot numbers manufactured to date

    Distribution

    Worldwide Distribution: USA (nationwide) and the country of Germany.

    Quantity

    4,172 units