# FDA recall Z-2145-2020

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

## Product

Hip Products   Item Number:  1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM  2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM  3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26  Product Usage: Hemi hip arthroplasty.

## 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-2145-2020
- **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-2145-2020

## Citation

> AI Analytics. FDA recall Z-2145-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2145-2020. Source: US FDA. Licensed CC0.

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