# FDA recall Z-0712-2018

> **Atrium Medical Corporation** · Class II · device recall initiated 2017-11-22.

## Product

ProLite Mesh - mesh, surgical, polymeric    ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.

## Reason for recall

An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298.   ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.

## Distribution

Internationally to Spain only.

## Key facts

- **Recall number:** Z-0712-2018
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-22
- **Report date:** 2018-03-07
- **Termination date:** 2018-07-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Merrimack, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0712-2018

## Citation

> AI Analytics. FDA recall Z-0712-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0712-2018. Source: US FDA. Licensed CC0.

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