{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Lewisville",
      "address_1": "3451 Plano Pkwy",
      "reason_for_recall": "There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.",
      "address_2": "",
      "product_quantity": "4,172 units",
      "code_info": "86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx    All lot numbers manufactured to date",
      "center_classification_date": "20140225",
      "distribution_pattern": "Worldwide Distribution: USA (nationwide) and the country of Germany.",
      "state": "TX",
      "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.",
      "report_date": "20140305",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Orthofix, Inc",
      "recall_number": "Z-1089-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "66660",
      "termination_date": "20141209",
      "more_code_info": "",
      "recall_initiation_date": "20131029",
      "postal_code": "75056-9453",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}