{
  "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": "West Lake Hills",
      "address_1": "1250 S Capital of Texas Hwy Ste 600",
      "reason_for_recall": "Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.",
      "address_2": "Bldg # 3",
      "product_quantity": "120 units",
      "code_info": "Lot numbers:  10923, 109231, 11476, 11993, WT20150630A",
      "center_classification_date": "20171019",
      "distribution_pattern": "US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO",
      "state": "TX",
      "product_description": "Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System      The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.",
      "report_date": "20171025",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Genesys Orthopedics Systems, LLC",
      "recall_number": "Z-0040-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "78181",
      "termination_date": "20180719",
      "more_code_info": "",
      "recall_initiation_date": "20151105",
      "postal_code": "78746-6446",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}