{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Cooper City",
      "address_1": "8963 Stirling Rd Ste 8",
      "reason_for_recall": "Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that updated information is provided to all accounts.",
      "address_2": "",
      "product_quantity": "75 sets",
      "code_info": "ALL Lots of devices are affected - IFU's are added at the time of fulfillment.    FlareHawk Instructions for Use 1- IFU-0150, Rev E  FlareHawk Surgical Technique Manual STM-00001, Rev A  FlareHawk Surgical Technical Manual 1-STM-0336, Rev C",
      "center_classification_date": "20181107",
      "distribution_pattern": "US nationwide in the states of AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, LA, MA, MS, NJ, NV, NY, OH, OR, PA, RI, SC, TX, and VA.",
      "state": "FL",
      "product_description": "FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease.",
      "report_date": "20181114",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Integrity Implants Inc.",
      "recall_number": "Z-0405-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81247",
      "termination_date": "20190506",
      "more_code_info": "",
      "recall_initiation_date": "20180227",
      "postal_code": "33328-5113",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}