Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Azure Anterior Cervical Plate System Recalled by Orthofix, Inc Due to There is a possibility that the locking mechanism...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Orthofix, Inc directly.
Affected Products
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.
Quantity: 4,172 units
Why Was This Recalled?
There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Orthofix, Inc
Orthofix, Inc has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report