# FDA recall Z-0306-2020

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2019-10-10.

## Product

TM Ankle and Ankle Talus L/R, Item Nos. 00450001100  00450001200  00450001300  00450001400  00450001500  00450001600  00450002100  00450002200  00450002300  00450002400  00450002500  00450002600

## Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

## Distribution

Distributed nationwide.

## Key facts

- **Recall number:** Z-0306-2020
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-10
- **Report date:** 2019-11-13
- **Termination date:** 2020-05-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2020

## Citation

> AI Analytics. FDA recall Z-0306-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0306-2020. Source: US FDA. Licensed CC0.

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