# FDA recall Z-0222-2023

> **X-NAV Technologies, LLC** · Class II · device recall initiated 2022-09-28.

## 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.

## Distribution

US Nationwide distribution and Foreign country of: Canada

## Key facts

- **Recall number:** Z-0222-2023
- **Recalling firm:** X-NAV Technologies, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-28
- **Report date:** 2022-11-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lansdale, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0222-2023

## Citation

> AI Analytics. FDA recall Z-0222-2023. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-0222-2023. Source: US FDA. Licensed CC0.

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