{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Leesburg",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82716",
      "recalling_firm": "K2M, Inc",
      "address_1": "600 Hope Pkwy SE",
      "address_2": "N/A",
      "postal_code": "20175-4428",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "The products were distributed to the following US states:  FL, KY, MI, PA, SC, and WV.",
      "recall_number": "Z-1491-2019",
      "product_description": "Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015)    Product Usage:  The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.",
      "product_quantity": "462 total",
      "reason_for_recall": "The products are mislabeled.",
      "recall_initiation_date": "20190418",
      "center_classification_date": "20190525",
      "termination_date": "20200619",
      "report_date": "20190605",
      "code_info": "All lots in distribution"
    }
  ]
}