{
  "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": [
    {
      "status": "Terminated",
      "city": "Raynham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "79494",
      "recalling_firm": "DePuy Spine, Inc.",
      "address_1": "325 Paramount Dr",
      "address_2": "N/A",
      "postal_code": "02767-5199",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "International Distribution (outside the U.S.) only: Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Austria, Switzerland, Australia, Hungary, Croatia, and Sweden.",
      "recall_number": "Z-1300-2018",
      "product_description": "Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630)    The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).",
      "product_quantity": "1972",
      "reason_for_recall": "Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.",
      "recall_initiation_date": "20171215",
      "center_classification_date": "20180403",
      "termination_date": "20200413",
      "report_date": "20180411",
      "code_info": "Lot numbers: 129385  129386  133824  133825  133826  133827  133828  133829  133830  133831  134609  134610  134611  134612  134613  134614  135476  135477  135478  145664  145665  145666  145667  145668  145669  145670  145671  147555  152905  152906  152908  153880  153881  153882  153883  153884  153885  153886  153888  153889  154956  154957  HVKBHH  HVKBHJ"
    }
  ]
}