# FDA recall Z-0200-2018

> **Exactech, Inc.** · Class II · device recall initiated 2017-05-16.

## Product

Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc.,       Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.

## Reason for recall

Possible inner labeling and packaged device not matching the outer label on the box.

## Distribution

Distributed in North Carolina

## Key facts

- **Recall number:** Z-0200-2018
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-16
- **Report date:** 2017-12-13
- **Termination date:** 2021-04-22

- **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-0200-2018

## Citation

> AI Analytics. FDA recall Z-0200-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0200-2018. Source: US FDA. Licensed CC0.

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