# FDA recall Z-2153-2020

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

## Product

Knee   Products:  183742	        Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM  EP-183608	Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM  EP-183608	Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM  183744	        Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM  183742	        Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM  EP-183608	Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM  EP-183608	Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM  Product Usage: Knee prosthesis

## 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-2153-2020
- **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-2153-2020

## Citation

> AI Analytics. FDA recall Z-2153-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2153-2020. Source: US FDA. Licensed CC0.

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