# FDA recall Z-2152-2020

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

## Product

Knee Products:  189420	Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM  189422	Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM  189442	Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM  189460	Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM  189440	Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM  189460	Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM  189420	Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM  189460	Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM  189426	Vanguard Knee System, PS Mono Lock Tibial Bearing, 16 MM X 63 MM  189440	Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM  189460	Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM

## 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-2152-2020
- **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-2152-2020

## Citation

> AI Analytics. FDA recall Z-2152-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2152-2020. Source: US FDA. Licensed CC0.

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