# FDA recall Z-0489-2022

> **DePuy Orthopaedics, Inc.** · Class II · device recall initiated 2021-12-07.

## Product

GLOBAL UNITE STD STEM SZ 14  Product Code: 110014100

## Reason for recall

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

## Distribution

Worldwide distribution -  US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

## Key facts

- **Recall number:** Z-0489-2022
- **Recalling firm:** DePuy Orthopaedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-07
- **Report date:** 2022-01-19
- **Termination date:** 2024-05-17

- **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-0489-2022

## Citation

> AI Analytics. FDA recall Z-0489-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0489-2022. Source: US FDA. Licensed CC0.

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