# FDA recall Z-2321-2020

> **Biomet** · Class II · device recall initiated 2020-05-14.

## Product

A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM  HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.

## Reason for recall

Distributed to the field without having completed design history files or design transfer activities

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.

## Key facts

- **Recall number:** Z-2321-2020
- **Recalling firm:** Biomet
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-14
- **Report date:** 2020-06-17
- **Termination date:** 2021-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2321-2020

## Citation

> AI Analytics. FDA recall Z-2321-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2321-2020. Source: US FDA. Licensed CC0.

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