{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Houston",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84977",
      "recalling_firm": "Trilliant Surgical, LLC",
      "address_1": "727 N Shepherd Dr Ste 100",
      "address_2": "N/A",
      "postal_code": "77007-1320",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distribution to US states: AZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI,  MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, SD, TN, TX, VA, WA, WI, WY, and PR.  There was government distribution and no military distribution.    Foreign distribution to Australia, India, Italy, Panama, and Turkey.",
      "recall_number": "Z-1607-2020",
      "product_description": "Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001.  The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.",
      "product_quantity": "4 systems total for both Twist Sublatar and Disco Sublatar",
      "reason_for_recall": "Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters.  This recall of IFU occurred in 2018.",
      "recall_initiation_date": "20180719",
      "center_classification_date": "20200330",
      "report_date": "20200408",
      "code_info": "IFUs previous to Document #900-01-003 Rev. M and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C."
    }
  ]
}