Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anter...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1089-2014.
There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1089-2014.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Orthofix, Inc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1089-2014.
Orthofix, Inc
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report a food, supplement, or cosmetic problem to the FDA
If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Orthofix, Inc Recall FAQ
Orthofix, Inc is the subject of a medical implants safety report: Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anter.... The notice was published on October 29, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 4,172 units are potentially affected.