The Recall Desk
ModerateFDA (Devices)·Z-0533-2021·Announced 2020-12-09

Ethicon Recalls PROCEED Surgical Mesh Due to Foreign Material in Packaging

Ethicon is recalling 15 units of PROCEED Surgical Mesh because a hair was found inside the primary packaging of a sterile device.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a foreign material (hair) in sterile packaging, which is a contamination issue but does not involve high-risk pathogens or structural defects.

Plain-English summary

Ethicon, Inc. is recalling 15 units of PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm. The recall is being conducted because the device is sterile, and a customer reported finding a hair inside the primary packaging of a single unit.

The impacted lot, PHG118, consisted of 295 units distributed to 27 countries worldwide, excluding the United States. Ethicon is specifically recalling the 15 units distributed in South Korea in accordance with requirements from South Korea's Ministry of Food and Drug Safety (MFDS). The product code is PCDG1, the GTIN is 10705031047716, and the expiration date is 07/31/2021.

Healthcare providers and patients who have used or possess this specific lot of PROCEED Surgical Mesh should contact Ethicon, Inc. for further instructions on how to return the product or obtain a replacement.

The recalled product

Product
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Manufacturer
Ethicon, Inc.
Category
Medical Device — Surgical Mesh
Hazard

Distribution

Distribution scope not specified by the agency.

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