{
  "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": "Gainesville",
      "address_1": "2320 NW 66th Ct",
      "reason_for_recall": "The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.",
      "address_2": "",
      "product_quantity": "242",
      "code_info": "size 3.5mm x 10mm, Catalog #05-000-20-3510, Lot Number #35917001.  size 3.5mm x 14mm, Catalog #05-000-20-3514, Lot Number 35917002 and 40023002.  size 3.5mm x 20mm, Catalog #05-000-20-3520, Lot Number 35917003.  size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917004.  size 4.0mm x 14mm, Catalog #05-000-20-4014, Lot Number 35917005.  size 4.0mm x  20mm, Catalog #05-000-20-4020, Lot Number 35917006.  size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917007.  1/4 Shank, size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917008.  1/4 Shank, size 3.5mm x 30mm, Catalog #05-000-20-3530, Lot Number 35917009.  1/4 Shank, size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917010.  1/4 Shank, size 4.0mm x 30mm, Catalog #05-000-20-4030, Lot Number 35917011.",
      "center_classification_date": "20140318",
      "distribution_pattern": "USA Distribution including the states of  FL, NY, OR, IL, PA, MO and NJ.",
      "state": "FL",
      "product_description": "Gibralt Spine System Polyaxial Screw    Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.",
      "report_date": "20140326",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Exactech, Inc.",
      "recall_number": "Z-1217-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67486",
      "termination_date": "20140804",
      "more_code_info": "",
      "recall_initiation_date": "20140106",
      "postal_code": "32653-1630",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}