{
  "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": "2026-10-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Santa Clara",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99868",
      "recalling_firm": "SI-BONE, Inc.",
      "address_1": "471 El Camino Real Ste 101",
      "address_2": "",
      "postal_code": "95050-4482",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.",
      "recall_number": "Z-0146-2027",
      "product_description": "iFuse TORQ Implant System  Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)",
      "product_quantity": "100 units",
      "reason_for_recall": "The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.",
      "recall_initiation_date": "20260821",
      "center_classification_date": "20261009",
      "report_date": "20261021",
      "code_info": "10055T-UDI:00810055520077/Lot:9142871 10060T-UDI:00810055520084/Lot:9137761 10065T-UDI:00810055520091/Lot:9139213 10080T-UDI:00810055520121/Lot:9137781 11580T-UDI:00810055520367/Lot:9142911",
      "more_code_info": ""
    }
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}