Device product
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.
Z-1089-2014
Product summary
- Firm
- Orthofix, Inc
- Event
- Event 66660
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,172 units
- Official record key
device-enforcement:Z-1089-2014
Official wording
Reason: There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Code information: 86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx All lot numbers manufactured to date
Distribution pattern: Worldwide Distribution: USA (nationwide) and the country of Germany.
Derived failure modes
-
Unknown
There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.