Recall Z-0222-2023 · QRY Dental Navigation System
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
| Date | Nov 10, 2022 (initiated Sep 28, 2022) |
| Status | Open, Classified |
| 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 |
| Quantity | 102 units |
| Distribution | US Nationwide distribution and Foreign country of: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211701 | X-Guide® Surgical Navigation System X-Nav Technologies, LLC, Feb 1, 2022 |