Z-0222-2023Class II

X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark...

Name: Z-0222-2023 X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark...
Creator: X-NAV Technologies, LLC
Published: 2022-09-28
License: https://open.fda.gov/license/

X-NAV Technologies, LLC / initiated 2022-09-28 / Open, Classified / root cause: manufacturing process

FDA source

X-NAV Technologies, LLC began a recall of X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673 on 2022-09-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0222-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-28
Posted: 2022-11-10
Recalling firm: X-NAV Technologies, LLC
Product: X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Product code: QRY Dental Navigation System
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 tag: manufacturing process
FDA root cause: Process control
Action: X-Nav issued letters dated 9/30/2022 via First Class Mail to potentially affected users on 10/3/22. Letter states reason for recall, health risk and action to take: The 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. After 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. 1. PROBE TOOL IS GOOD. If your Probe Tool matches the good Probe Tool pictures above, it may be used as-is. 2. PROBE 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. 3. YOU 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. x-navtech.com | Customer Service: 1-267-436-0420 Ext. 2 | [email protected]
Quantity in commerce: 102 units
Distribution: US Nationwide distribution and Foreign country of: Canada
Product codes and lots: UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0222-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0222-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-10

Product code QRY

K211701Class IIX-Guide® Surgical Navigation SystemX-Nav Technologies, LLC / cleared 2022-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)