{
  "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": "Sugar Land",
      "address_1": "12615 W Airport Blvd",
      "reason_for_recall": "This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube.  Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.",
      "address_2": "Ste 200",
      "product_quantity": "12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution",
      "code_info": "Lot numbers: 019715, 019716, 019942, 019943, 019977, 019978, 020102, 020103, 020104, 020105, 020106, 020107, 020108, 020609, 020782,   021539, 021663, 022097, 022098, 022099, 022122, 022123, 022124, 022371, 022372, 022790, 022791, 022792, 022794, 022795, 022796, 022827, 022828, and 023266.",
      "center_classification_date": "20120914",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of : Australia and Taiwan.",
      "state": "TX",
      "product_description": "Sterile Distraction Screws of 3 different sizes:  12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand    Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine.",
      "report_date": "20120926",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Tedan Surgical Innovations Llc",
      "recall_number": "Z-2385-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62899",
      "termination_date": "20130731",
      "more_code_info": "",
      "recall_initiation_date": "20120611",
      "postal_code": "77478-6203",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}