# FDA recall Z-2155-2020

> **Biomet, Inc.** · Class II · device recall initiated 2020-04-17.

## Product

Knee Products:  US154709	Knees	Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8  US154722	Knees	Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5  US154725	Knees	Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6  US154705	Knees	Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B6  US154707	Knees	Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B7  US154713	Knees	Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C5  US154719	Knees	Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C8  US154720	Knees	Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D4  US154721	Knees	Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D4  US154723	Knees	Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Le

## Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY,                        HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE,                             SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

## Key facts

- **Recall number:** Z-2155-2020
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-17
- **Report date:** 2020-06-03
- **Termination date:** 2021-06-25

- **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-2155-2020

## Citation

> AI Analytics. FDA recall Z-2155-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2155-2020. Source: US FDA. Licensed CC0.

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