# FDA recall Z-2239-2019

> **BioPro, Inc.** · Class II · device recall initiated 2019-06-25.

## Product

K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine.

## Reason for recall

Manufacturing flaw in the sterile barrier system

## Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of  Ecuador, Scotland.

## Key facts

- **Recall number:** Z-2239-2019
- **Recalling firm:** BioPro, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-25
- **Report date:** 2019-08-21
- **Termination date:** 2020-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Port Huron, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2239-2019

## Citation

> AI Analytics. FDA recall Z-2239-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2239-2019. Source: US FDA. Licensed CC0.

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