Recall Z-1089-2014— Orthofix, Inc

Name: FDA recall Z-1089-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-29

Class II · Terminated

Class II FDA medical device recall by Orthofix, Inc, initiated 2013-10-29, terminated 2014-12-09. It names one FDA 510(k) clearance: K130825. 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..

Recalling firm: Orthofix, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-10-29
Terminated: 2014-12-09
Firm location: Lewisville, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K130825 — AZURE ANTERIOR CERVICAL PLATE SYSTEMOrthofix, Inc.·cleared 2013-05-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.