FDA Device recall 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 C…
- FDA Device
- Class II
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class II recall of Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior C… by Orthofix, citing there is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1089-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-29 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthofix |
| Distribution | US |
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.
Reason
There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Identifiers
| code_info | 86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx All lot numbers manufactured to date |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1089-2014%22
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