{
  "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": "2026-10-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "206520",
      "product_res_number": "Z-1392-2024",
      "event_date_initiated": "2024-03-04",
      "event_date_posted": "2024-03-29",
      "recall_status": "Open, Classified",
      "res_event_number": "94175",
      "product_code": "QRY",
      "k_numbers": [
        "K232148"
      ],
      "product_description": "X-Guide Handpiece Adaptor Sleeve 1, Model P010701",
      "code_info": "UDI-DI: 00817421021480;\nLot: 2308010012",
      "firm_fei_number": "3011764595",
      "recalling_firm": "X-NAV Technologies, LLC",
      "address_1": "1555 Bustard Rd Ste 75 1555 Bustard Rd",
      "address_2": "Ste 75",
      "city": "Lansdale",
      "state": "PA",
      "postal_code": "19446-5731",
      "reason_for_recall": "The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.",
      "root_cause_description": "Use error",
      "action": "An URGENT MEDICAL DEVICE RECALL dated 3/4/24 was sent to customers.\n\nAction To Be Taken by the User\n\nIdentify if you possess any of the affected devices. The lot numbers of the affected devices are the following:\n2308010012\t2306020012\t2310010012\n\nIf the lot number on your device is not one of the above, then that Adaptor Sleeve is not part of this Recall. If you have a defective device, quarantine the device so that it is prevented from being used. Finally, destroy the device or return to X-Nav Technologies, LLC. Return the response form.\n\nX-Nav will ship all affected users a new Handpiece Adaptor Sleeve to replace their defective unit free of charge.\n\nThis notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. (As appropriate)\n\nPlease transfer this notice to other organizations on which this action has an impact. (As appropriate)\n\nPlease maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.\n\nPlease report all device-related incidents to the manufacturer, distributor or local representative, and the national Competent Authority if appropriate, as this provides important feedback.",
      "product_quantity": "88 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.",
      "openfda": {
        "k_number": [
          "K222750",
          "K232148",
          "K261321",
          "K211701",
          "K253954",
          "K222049"
        ],
        "registration_number": [
          "3012787974",
          "3011874573",
          "3011764595",
          "3014552222"
        ],
        "fei_number": [
          "3012787974",
          "3011874573",
          "3011764595",
          "3014552222"
        ],
        "device_name": "Dental Navigation System",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.4120",
        "device_class": "2"
      }
    }
  ]
}