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.
This recall has been terminated (originally issued February 25, 2014).
- Company
- Orthofix, Inc
- Recall Initiated
- October 29, 2013
- Posted
- February 25, 2014
- Terminated
- December 9, 2014
- Recall Number
- Z-1089-2014
- Quantity
- 4,172 units
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
Reason for Recall
There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Distribution
Worldwide Distribution: USA (nationwide) and the country of Germany.
Lot / Code Info
86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx All lot numbers manufactured to date
Root Cause
Component design/selection
Action Taken
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 Azure plates, please follow these Instructions. 1. Check you inventory of Azura Implant Trays.. 2. Complete the attached form with the quantity you are returning. 3. Contact your local Orthofix representative or Orthofix customer service representative at 888--298-5700 for return instructions and shipment information and replacement with a different Orthofix Anterior Cervical Plate System. .