# FDA recall Z-0398-2022

> **Civco Medical Instruments Co. Inc.** · Class II · device recall initiated 2021-10-08.

## Product

VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

## Reason for recall

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

## Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.

## Key facts

- **Recall number:** Z-0398-2022
- **Recalling firm:** Civco Medical Instruments Co. Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-08
- **Report date:** 2021-12-29
- **Termination date:** 2024-09-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kalona, IA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0398-2022

## Citation

> AI Analytics. FDA recall Z-0398-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0398-2022. Source: US FDA. Licensed CC0.

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