# FDA recall Z-0533-2021

> **Ethicon, Inc.** · Class II · device recall initiated 2020-10-23.

## Product

PROCEED Surgical Mesh  Hernia Mesh Oval, 15 cm x 20 cm

## Reason for recall

The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.

## Distribution

The impacted lot (295 units) was distributed to 27 countries worldwide excluding the US. However, the firm is only recalling the 15 units that were distributed in South Korea due to South Korea's Ministry of Food and Drug Safety (MFDS) requirements.

## Key facts

- **Recall number:** Z-0533-2021
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-23
- **Report date:** 2020-12-09
- **Termination date:** 2022-12-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerville, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0533-2021

## Citation

> AI Analytics. FDA recall Z-0533-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0533-2021. Source: US FDA. Licensed CC0.

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