# FDA recall Z-2926-2020

> **Exactech, Inc.** · Class II · device recall initiated 2020-08-10.

## Product

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.

## Reason for recall

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm,  were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error.  The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.

## Distribution

Domestic: CO,FL,OK, PA.   International: Chile

## Key facts

- **Recall number:** Z-2926-2020
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-08-10
- **Report date:** 2020-09-09

- **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-2926-2020

## Citation

> AI Analytics. FDA recall Z-2926-2020. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-2926-2020. Source: US FDA. Licensed CC0.

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