# FDA recall Z-3249-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-08-02.

## Product

Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment,  Model Number 185221     Intended for use in Total Knee Arthroplasty

## Reason for recall

The implant only has one bolt in the sterile package but it should have had two.

## Distribution

Worldwide Distribution: US (nationwide) to the following US states:  AZ, KS, NM, NV, and UT; and to countries of:  Australia and Netherlands.

## Key facts

- **Recall number:** Z-3249-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-02
- **Report date:** 2018-10-03
- **Termination date:** 2019-04-25

- **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-3249-2018

## Citation

> AI Analytics. FDA recall Z-3249-2018. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-3249-2018. Source: US FDA. Licensed CC0.

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