Class II — X-NAV Technologies, LLC
| Recalling firm | X-NAV Technologies, LLC. |
|---|---|
| Registered facility | X-NAV TECHNOLOGIES, LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673 |
| Quantity | 102 units |
| Distribution | US Nationwide distribution and Foreign country of: Canada |
| Initiated | 2022-09-28 |
| Classified | 2022-11-10 |
| Recall number | Z-0222-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — X-NAV Technologies, LLC (Z-0222-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91067/
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