# FDA recall Z-0403-2021

> **Synthes (USA) Products LLC** · Class III · device recall initiated 2020-09-21.

## Product

DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI)  Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

## Reason for recall

Incorrectly Labeled  'general medical device,'  printed on the statutory label of the SYNMESH CAGE SYSTEM  instead of 'specially controlled medical device"

## Distribution

International distribution the country of Japan Only.

## Key facts

- **Recall number:** Z-0403-2021
- **Recalling firm:** Synthes (USA) Products LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-21
- **Report date:** 2020-11-11
- **Termination date:** 2022-12-30

- **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-0403-2021

## Citation

> AI Analytics. FDA recall Z-0403-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0403-2021. Source: US FDA. Licensed CC0.

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