# FDA recall Z-0101-2023

> **Synthes (USA) Products LLC** · Class II · device recall initiated 2022-09-27.

## Product

DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

## Reason for recall

The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0101-2023
- **Recalling firm:** Synthes (USA) Products LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-27
- **Report date:** 2022-10-26

- **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-0101-2023

## Citation

> AI Analytics. FDA recall Z-0101-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0101-2023. Source: US FDA. Licensed CC0.

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