{
  "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": "Warsaw",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77750",
      "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": "Visit",
      "distribution_pattern": "Worldwide distribution: US (nationwide) in states of: AR, GA, MI, OH, and TX; and countries of:Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.",
      "recall_number": "Z-0161-2018",
      "product_description": "ROSA Surgical Device 2.5.8      It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.",
      "product_quantity": "29 devices(8 US and 21 OUS)",
      "reason_for_recall": "Software corrections reactivating the cooperative endoscopy mode.",
      "recall_initiation_date": "20140604",
      "center_classification_date": "20171121",
      "termination_date": "20200616",
      "report_date": "20171129",
      "code_info": "Serial No. RO10011, RO14033, RO14031, RO14035, RO13027, RO13023, RO10014, RO10009, RO10010, RO14030, RO11016, RO11017, RO12022, RO14029, RO14032, RO08003, RO09004, RO10007, RO10013, RO12018, RO12019, RO13025, RO14034, RO11015, RO13024, RO09005, RO13026, RO12021, and RO12020."
    }
  ]
}