Class II — Orthofix, Inc
| Recalling firm | ORTHOFIX SRL |
|---|---|
| Registered facility | ORTHOFIX SRL (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation. |
| 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 t… |
| Quantity | 4,172 units |
| Distribution | Worldwide Distribution: USA (nationwide) and the country of Germany. |
| Initiated | 2013-10-29 |
| Classified | 2014-02-25 |
| Terminated | 2014-12-09 |
| Recall number | Z-1089-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Orthofix, Inc (Z-1089-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66660/
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