Orthofix Azure Anterior Cervical Plate System Recall for Fracture Risk
Orthofix is recalling Azure Anterior Cervical Plate Systems because the locking mechanism may fracture during or after implantation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fracture) in a spinal implant, which meets the criteria for a Severe rating due to the risk of significant injury.
Plain-English summary
Orthofix, Inc. is recalling the Azure Anterior Cervical Plate System, a temporary implant intended for anterior fixation to the cervical spine. The recall involves 4,172 units of the 2-Level Plate, 36 mm, made of implant grade titanium and nitinol.
The recall is being conducted because there is a possibility that the locking mechanism of the plate may fracture during or after implantation. The affected lots include all lot numbers manufactured to date, specifically codes 86-01xx, 86-02xx, 86-03xx, 86-04xx, and 86-05xx.
The product was distributed worldwide, including nationwide in the United States and in Germany. Patients who have had this device implanted should contact their healthcare provider for evaluation.
The recalled product
- 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.…
- Manufacturer
- Orthofix, Inc
- Affected units
- 4,172
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 86-01xx
- 86-02xx
- 86-03xx
- 86-04xx
- 86-05xx All lot numbers manufactured to date
Distribution
Distributed nationwide across the United States.
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