# FDA recall Z-0295-2019

> **Arthrex, Inc.** · Class II · device recall initiated 2018-08-27.

## Product

Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System    Product Usage:  The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.

## Reason for recall

The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.

## Distribution

Worldwide - Nationwide Distribution in the states of AL, CA, CO, FL, ID, IL, MA, MD, MI, MO, NC, NE, NY, PA, SC, TN, TX, UT, WI.  and the countries of  Austria, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Italy, Kuwait, Lithuania, Netherlands, Norway, Poland, Russia, Slovakia, Spain and Switzerland.

## Key facts

- **Recall number:** Z-0295-2019
- **Recalling firm:** Arthrex, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-08-27
- **Report date:** 2018-11-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Naples, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0295-2019

## Citation

> AI Analytics. FDA recall Z-0295-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0295-2019. Source: US FDA. Licensed CC0.

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