# FDA recall Z-2183-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-05-11.

## Product

Vanguard Knee System PS Tibial Bearing, Part Number 183621     Intended for use in knee joint replacement procedures.

## Reason for recall

The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.

## Distribution

Worldwide distribution: US (nationwide) to states of: AR, CA, FL, GA, IL, IN, KS, MI, MN, MS, NC, OH, PA, TN, TX, and WV and country of: Canada.

## Key facts

- **Recall number:** Z-2183-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-11
- **Report date:** 2018-06-20
- **Termination date:** 2019-11-21

- **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-2183-2018

## Citation

> AI Analytics. FDA recall Z-2183-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2183-2018. Source: US FDA. Licensed CC0.

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