# FDA recall Z-1032-2019

> **ACell, Inc** · Class II · device recall initiated 2019-02-14.

## Product

Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

## Reason for recall

The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.

## Distribution

US nationwide distribution in the state of CA.

## Key facts

- **Recall number:** Z-1032-2019
- **Recalling firm:** ACell, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-14
- **Report date:** 2019-03-27
- **Termination date:** 2020-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbia, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1032-2019

## Citation

> AI Analytics. FDA recall Z-1032-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1032-2019. Source: US FDA. Licensed CC0.

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