FDA Medical Device Recalls (openFDA)
X-NAV Technologies, LLC: X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
- Recall number
- Z-0222-2023
- 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
- Status
- Open, Classified
- Initiated
- 2022-09-28
- Posted
- 2022-11-10
- Terminated
- not on file
- Reason
- 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
- 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 | orders@x-navtech.com
- Quantity
- 102 units
- Distribution
- US Nationwide distribution and Foreign country of: Canada
- Lot, serial or model codes
- UDI-DI: (01)00817421020995 (10) 2007010010 Lot number: 2007010010
- 510(k) numbers
- ["K211701"]
- PMA numbers
- not on file
- Product code
- QRY
- Firm FEI
- 3011764595
- Firm city
- Lansdale
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28