{
  "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": "Austin",
      "address_1": "1250 S Capital Of Texas Hwy",
      "reason_for_recall": "The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.",
      "address_2": "Bldg #3, Suite 600",
      "product_quantity": "642",
      "code_info": "The devices being recalled have a catalog number of G826 and a lot number of 11406.",
      "center_classification_date": "20140922",
      "distribution_pattern": "Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.",
      "state": "TX",
      "product_description": "Circular Lock Screws, part # G826, lot # 11406.  The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System.  The TiLock Pedicle Screw 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 thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).",
      "report_date": "20141001",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Genesys Orthopedics Systems, LLC",
      "recall_number": "Z-2677-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67900",
      "termination_date": "20150515",
      "recall_initiation_date": "20140402",
      "postal_code": "78746-6446",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}