# FDA recall Z-2149-2020

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

## Product

Knee Products:  155308	Knees	AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM  155326	Knees	AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM  155330	Knees	AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM  155344	Knees	AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM  155346	Knees	AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM  155326	Knees	AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM  155328	Knees	AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM  155388	Knees	AGC Knee System PS Molded Tibial component, 18 MM X 85 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-2149-2020
- **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-2149-2020

## Citation

> AI Analytics. FDA recall Z-2149-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2149-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*