X-Guide X-Mark Probe Tool -used for registering edentulous patients… — Class II medical device recall Z-0222-2023
Ongoing recall by X-NAV Technologies, LLC, reported 2022-11-16, distributed nationwide. Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible
| Recall number | Z-0222-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | X-NAV Technologies, LLC, Lansdale, PA, United States |
| Recall initiated | 2022-09-28 |
| Classified | 2022-11-10 |
| Reported by FDA | 2022-11-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 102 units |
| UPC / GTIN / UDI-DI | 00817421020995 |
| Lot numbers | 2007010010 |
| Model numbers | P010673 |
Product
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0222-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.