{
  "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": "South Jordan",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85485",
      "recalling_firm": "Merit Medical Systems, Inc.",
      "address_1": "1600 W Merit Pkwy",
      "address_2": "N/A",
      "postal_code": "84095-2416",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: US Nationwide distribution including in the states of  (TX, UT, PA, KY, TX, AR, CA, and PA) which included one (1) government/military consignee in KY; and the countries of (Germany, Switzerland, and New Zealand).",
      "recall_number": "Z-2067-2020",
      "product_description": "DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).",
      "product_quantity": "228",
      "reason_for_recall": "Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.",
      "recall_initiation_date": "20200213",
      "center_classification_date": "20200521",
      "termination_date": "20210226",
      "report_date": "20200527",
      "code_info": "Lot number: AAD-1801-16 and UDI: (01)00884450374399(17)221231(10)AAD-1801-16;  Lot number: AAD-1801-17 and UDI: (01)00884450374399(17)221231(10)AAD-1801-17;  Lot number: AAD-1803-01 and UDI: (01)00884450374399(17)230331(10)AAD-1803-01;  Lot number: AAD-1804-05 and UDI: (01)00884450374399(17)230430(10)AAD-1804-05;  Lot number: AAD-1901-07 and UDI: (01)00884450374399(17)231231(10)AAD-1901-07;  Lot number: AAD-1904-04 and UDI: (01)00884450374399(17)240430(10)AAD-1904-04."
    }
  ]
}