FDAFDA · Food and drugs·Recall number Z-1089-2014
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.
Published March 5, 2014 · Recall initiated: October 29, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthofix, Inc
- Distributor
- Worldwide Distribution: USA (nationwide) and the country of Germany.
- Lot
- 86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx All lot numbers manufactured to date
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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