# FDA recall Z-1543-2020

> **Biomet, Inc.** · Class II · device recall initiated 2020-02-17.

## Product

Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.

## Reason for recall

A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

## Distribution

International distribution in the countries of Canada, Japan, Netherlands, South Korea.

## Key facts

- **Recall number:** Z-1543-2020
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-17
- **Report date:** 2020-04-01
- **Termination date:** 2022-05-31

- **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-1543-2020

## Citation

> AI Analytics. FDA recall Z-1543-2020. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1543-2020. Source: US FDA. Licensed CC0.

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