{
  "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": "2026-04-29",
    "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": "78443",
      "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 including France and Germany",
      "recall_number": "Z-0177-2018",
      "product_description": "Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device  The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumber vertebrae with a posterior approach.",
      "product_quantity": "2",
      "reason_for_recall": "A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.",
      "recall_initiation_date": "20151029",
      "center_classification_date": "20171128",
      "termination_date": "20200616",
      "report_date": "20171206",
      "code_info": "Serial #'s; SP14003 and SP14005"
    }
  ]
}