Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Azure

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Azure see related information
Date Initiated by Firm October 29, 2013
Date Posted February 25, 2014
Recall Status1 Terminated 3 on December 09, 2014
Recall Number Z-1089-2014
Recall Event ID 66660
510(K)Number K130825  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
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.
Code Information 86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx  All lot numbers manufactured to date
Recalling Firm/
Manufacturer		 Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information Contact Diana Easton
214-937-2509
Manufacturer Reason
for Recall		 There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
FDA Determined
Cause 2		 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 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. .
Quantity in Commerce 4,172 units
Distribution Worldwide Distribution: USA (nationwide) and the country of Germany.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = ORTHOFIX, INC.
-
-