# FDA recall Z-1523-2018

> **Sofradim Production** · Class II · device recall initiated 2018-02-23.

## Product

Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M    The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a reinforcing material.

## Reason for recall

There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.

## Distribution

Worldwide Distribution - USA (nationwide) Distribution to the states of:  CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, PA, TN, TX, VA, WA and WI, and to the countries of : Belgium, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Russian Federation, Spain, Switzerland, and UK.

## Key facts

- **Recall number:** Z-1523-2018
- **Recalling firm:** Sofradim Production
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-23
- **Report date:** 2018-05-02
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Trevoux, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1523-2018

## Citation

> AI Analytics. FDA recall Z-1523-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1523-2018. Source: US FDA. Licensed CC0.

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