# FDA recall Z-0307-2021

> **Exactech, Inc.** · Class II · device recall initiated 2020-09-25.

## Product

Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.

## Reason for recall

The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.

## Key facts

- **Recall number:** Z-0307-2021
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-25
- **Report date:** 2020-11-04
- **Termination date:** 2023-05-01

- **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-0307-2021

## Citation

> AI Analytics. FDA recall Z-0307-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0307-2021. Source: US FDA. Licensed CC0.

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