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Ethicon, Inc. recalls PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Recalled December 9, 2020 · FDA recall Z-0533-2021 · Ethicon
Hazard
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. · FDA Class II
Units
295 units distributed. Only 15 units are being recalled.
Sold at
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.
Description
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.
Product
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Manufacturer(s)
Ethicon, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →