Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 5, 2014
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
There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Orthofix, Inc recalled Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Ni… - a moderate-severity action.
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Ni… was recalled by Orthofix, Inc in March 5, 2014. Reason: There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or…. Check the official notice for the remedy. Verify recall #Z-1089-2014 with the FDA Devices before acting.
The recall
Orthofix, Inc issued this moderate-severity FDA Devices recall-There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- March 5, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1089-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1089-2014) was formally reported on March 5, 2014, with the manufacturer initiating the action on October 29, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Orthofix, Inc is listed as the recalling firm, operating out of Lewisville, TX. Federal records list the affected scope as 4,172 units.
The documented reason for this recall is: There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation. Distribution data in the federal record shows the product reached: Worldwide Distribution: USA (nationwide) and the country of Germany.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4,172 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1089-2014 |
| Date reported | March 5, 2014 |
| Date initiated | October 29, 2013 |
| Recalling firm | Orthofix, Inc |
| Firm location | Lewisville, TX |
| Affected scope | 4,172 units |
| Distribution | Worldwide Distribution: USA (nationwide) and the country of Germany. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1089-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Orthofix, Inc. Units affected: 4,172 units.
Why was this product recalled? ▼
There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-1089-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: USA (nationwide) and the country of Germany..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1089-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 5, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.