# FDA recall Z-2148-2020

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

## Product

Knee Products:  154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3  154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4  154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7  154355 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, B3  154361 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, C4  154366 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, D4  154370 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, E3  154375 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3  154375   Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3  154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4  154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4  154377 Oxford Par

## 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-2148-2020
- **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-2148-2020

## Citation

> AI Analytics. FDA recall Z-2148-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2148-2020. Source: US FDA. Licensed CC0.

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