{
  "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": "Total 57 boxes (49 boxes for Lot 2017111301 and 48 boxes for Lot 2018031401)",
      "code_info": "Item #: DS-0022  Lot #s:  2017111301  2018031401",
      "center_classification_date": "20200317",
      "distribution_pattern": "Worldwide.",
      "state": "TX",
      "product_description": "DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended 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-1505-2020",
      "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"
    }
  ]
}