Recall Z-1089-2014 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Orthofix, Inc
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. Pseudoarthrosi
| Date | Feb 25, 2014 (initiated Oct 29, 2013) |
| Status | Terminated |
| Reason | There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation. |
| Root cause | Component design/selection |
| Action | Orthofix sent a Urgent Medical Device Recall Notification dated October 29, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediate Action: 1. Immediately cease any further distribution or use of the AZURE" plates. 2. Notify your surgeons and staff customers that Azure" plates cannot be used and are to be returned to Orthofix. at no cost to you, see Instructions below. 3. Please complete the attached reply form indicating that you have received this letter. Product Return Instructions: To return the Azur |
| Quantity | 4,172 units |
| Distribution | Worldwide Distribution: USA (nationwide) and the country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130825 | AZURE ANTERIOR CERVICAL PLATE SYSTEM Orthofix, Inc., May 7, 2013 |