{
  "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": [
    {
      "country": "United States",
      "city": "Sugar Land",
      "address_1": "12615 W Airport Blvd Ste 200",
      "reason_for_recall": "The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.",
      "address_2": "",
      "product_quantity": "49 boxes (245 individual screws)",
      "code_info": "Item #: D-0012  Lot #: 2018011601",
      "center_classification_date": "20200317",
      "distribution_pattern": "Worldwide.",
      "state": "TX",
      "product_description": "D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.",
      "report_date": "20200325",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "TeDan Surgical Innovations LLC",
      "recall_number": "Z-1503-2020",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "84252",
      "termination_date": "20210112",
      "more_code_info": "",
      "recall_initiation_date": "20190218",
      "postal_code": "77478-6203",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}