{
  "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": "Lansdale",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73544",
      "recalling_firm": "X-NAV Technologies, LLC",
      "address_1": "1555 Bustard Rd Ste 75",
      "address_2": "N/A",
      "postal_code": "19446-5731",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC.",
      "recall_number": "Z-1391-2016",
      "product_description": "X-Guide Surgical Navigation System, X-Clip Bulk Kit    The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.",
      "product_quantity": "845 units (P007665)",
      "reason_for_recall": "The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy.  The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures.  The X-Clip contains three fiducial markers made from a Stainless Steel material.  The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3",
      "recall_initiation_date": "20160223",
      "center_classification_date": "20160414",
      "termination_date": "20161101",
      "report_date": "20160420",
      "code_info": "Model Numbers: P007665 X-Clip; Component of System P007839.  Note: P007665 X-Clip Component is distributed as X-Clip Bulk Kit PN P008381, package of 12 pieces P007665.",
      "more_code_info": ""
    }
  ]
}