Orthofix, Inc recalls Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only

Recalled March 5, 2014 · FDA recall Z-1089-2014 · Orthofix

Hazard

There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation. · FDA Class II

Units

4,172 units

Sold at

Worldwide Distribution: USA (nationwide) and the country of Germany.

Description

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 to the anterior aspect of the vertebral body by means of screw to to the cervical spine.

Manufacturer(s)

Orthofix, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →