{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Belgrade",
      "state": "MT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76842",
      "recalling_firm": "XTANT MEDICAL INC",
      "address_1": "664 Cruiser Ln",
      "address_2": "N/A",
      "postal_code": "59714-9719",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide in the states of: AZ, CA, CT, GA, LA, NV, OH, TX and in the country of  Mexico.",
      "recall_number": "Z-1884-2017",
      "product_description": "5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420.  The product is packaged in plastic bags with one piece per bag.    Product Usage:  The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).",
      "product_quantity": "97 units",
      "reason_for_recall": "The material type on the label may incorrectly state \u001cTi6Al-4V ELI\u001d. The rods are composed of Cobalt Chromium.",
      "recall_initiation_date": "20170412",
      "center_classification_date": "20170427",
      "termination_date": "20170816",
      "report_date": "20170503",
      "code_info": "Part number X077-0420, lot number 041218"
    }
  ]
}