{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78367",
      "recalling_firm": "Zimmer Biomet, Inc.",
      "address_1": "1800 W Center St",
      "address_2": "N/A",
      "postal_code": "46580-2304",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY,  PA and countries of   Australia and France",
      "recall_number": "Z-0167-2018",
      "product_description": "ROSA Brain 3.0.0    Usage:  The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.",
      "product_quantity": "18 (14 US and 4 OUS)",
      "reason_for_recall": "Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.",
      "recall_initiation_date": "20160720",
      "center_classification_date": "20171121",
      "termination_date": "20200616",
      "report_date": "20171129",
      "code_info": "Serial #'s:  BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, and   BR16021"
    }
  ]
}