Z-1089-2014Class II

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

Name: Z-1089-2014 Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix...
Creator: Orthofix, Inc
Published: 2013-10-29
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2013-10-29 / Terminated / root cause: design

FDA source

Orthofix, Inc began a recall of 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... on 2013-10-29. FDA classified it as Class II and gives the reason as "There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1089-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-29
Posted: 2014-02-25
Terminated: 2014-12-09
Recalling firm: Orthofix SRL
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.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Root cause tag: design
FDA 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 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.
Product codes and lots: 86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx All lot numbers manufactured to date

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1089-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1089-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-25

Product code KWQ

K130825Class IIAzure Anterior Cervical Plate SystemOrthofix, Inc. / cleared 2013-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)