# FDA recall Z-1392-2024

> **X-NAV Technologies, LLC** · Class II · device recall initiated 2024-03-04.

## Product

X-Guide Handpiece Adaptor Sleeve 1, Model P010701

## Reason for recall

The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

## Distribution

Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.

## Key facts

- **Recall number:** Z-1392-2024
- **Recalling firm:** X-NAV Technologies, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-04
- **Report date:** 2024-04-10

- **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-1392-2024

## Citation

> AI Analytics. FDA recall Z-1392-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1392-2024. Source: US FDA. Licensed CC0.

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