# FDA recall Z-1072-2022

> **Synthes (USA) Products LLC** · Class II · device recall initiated 2022-04-07.

## Product

Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21  24mm in length.

## Reason for recall

DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1072-2022
- **Recalling firm:** Synthes (USA) Products LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-07
- **Report date:** 2022-05-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1072-2022

## Citation

> AI Analytics. FDA recall Z-1072-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1072-2022. Source: US FDA. Licensed CC0.

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