# FDA recall Z-0361-2020

> **Exactech, Inc.** · Class II · device recall initiated 2019-10-02.

## Product

2.4mm x 2.5  Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.

## Reason for recall

Potential for the 2.4mm x 2.5  Fluted Pin Pouch to contain a single pin rather than four (4) as intended.

## Distribution

US Nationwide distribution in the states of GA, NY, OH, VA.

## Key facts

- **Recall number:** Z-0361-2020
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-02
- **Report date:** 2019-11-20
- **Termination date:** 2023-05-19

- **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-0361-2020

## Citation

> AI Analytics. FDA recall Z-0361-2020. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0361-2020. Source: US FDA. Licensed CC0.

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