# FDA recall Z-0238-2019

> **Synthes (USA) Products LLC** · Class II · device recall initiated 2018-09-12.

## Product

3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118     DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.

## Reason for recall

The product inside the package does not match the label.  The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.

## Distribution

US Distribution to the following states:  AR, AZ, FL, IL, NM, OH, and TX.

## Key facts

- **Recall number:** Z-0238-2019
- **Recalling firm:** Synthes (USA) Products LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-12
- **Report date:** 2018-10-31
- **Termination date:** 2020-04-10

- **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-0238-2019

## Citation

> AI Analytics. FDA recall Z-0238-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0238-2019. Source: US FDA. Licensed CC0.

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