{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "196626",
      "product_res_number": "Z-0222-2023",
      "event_date_initiated": "2022-09-28",
      "event_date_posted": "2022-11-10",
      "recall_status": "Open, Classified",
      "res_event_number": "91067",
      "product_code": "QRY",
      "k_numbers": [
        "K211701"
      ],
      "product_description": "X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration.\nCatalog Number:P010673",
      "code_info": "UDI-DI:\n(01)00817421020995\n(10) 2007010010\n\nLot number: 2007010010",
      "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": "Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip.",
      "root_cause_description": "Process control",
      "action": "X-Nav issued letters dated 9/30/2022 via First Class Mail to potentially affected users on 10/3/22.\nLetter states reason for recall, health risk and action to take:\n\nThe customers were instructed to cease use of the device until you have performed the inspection described on the second page of this letter. Review the pictures on the next page and compare them to the Probe Tool in your possession.\nAfter review, contact Customer Service at the contact options listed at the bottom of this page so that we may update our records with your findings. Report any of the below options.\n\n1.\tPROBE TOOL IS GOOD. If your Probe Tool matches the good Probe Tool pictures above, it may be used as-is.\n2.\tPROBE TOOL IS BROKEN. If your Probe Tool looks like either of the broken Probe Tool pictures above, we will send you a shipping label to return your existing Probe Tool.  We will replace it with a new one free of charge.\n3.\tYOU ARE UNSURE. If you are uncomfortable doing this inspection yourself or have doubt whether the Probe Tool is good, we will send you a shipping label to return your existing Probe Tool.  We will replace it with a new one free of charge.\n\nx-navtech.com | Customer Service: 1-267-436-0420 Ext. 2 | orders@x-navtech.com",
      "product_quantity": "102 units",
      "distribution_pattern": "US Nationwide distribution and Foreign country of: Canada",
      "openfda": {
        "k_number": [
          "K232148",
          "K222750",
          "K211701",
          "K222049"
        ],
        "device_name": "Dental Navigation System",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.4120",
        "device_class": "2",
        "registration_number": [
          "3014552222",
          "3011764595",
          "3012787974",
          "3011874573"
        ],
        "fei_number": [
          "3014552222",
          "3011764595",
          "3012787974",
          "3011874573"
        ]
      }
    }
  ]
}