# FDA recall Z-2289-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-05-24.

## Product

Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642    Product Usage: The product is intended for use in knee joint replacement arthroplasties.

## Reason for recall

Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.

## Distribution

Distributed to accounts in CA, CT, GA, IA, IN, LA, MA, MD, MN, MS, NJ, OH, PA, TN, TX, UT, VA, WI. Foreign distribution to Taiwan, Japan, and the Netherlands.

## Key facts

- **Recall number:** Z-2289-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-24
- **Report date:** 2018-07-04
- **Termination date:** 2020-04-07

- **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-2289-2018

## Citation

> AI Analytics. FDA recall Z-2289-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2289-2018. Source: US FDA. Licensed CC0.

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