# FDA recall Z-0012-2019

> **Exactech, Inc.** · Class II · device recall initiated 2018-08-21.

## Product

Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00    Product Usage:  Shoulder surgery

## Reason for recall

The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.

## Distribution

In the countries of Australia and France

## Key facts

- **Recall number:** Z-0012-2019
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-08-21
- **Report date:** 2018-10-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0012-2019

## Citation

> AI Analytics. FDA recall Z-0012-2019. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0012-2019. Source: US FDA. Licensed CC0.

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