FDA-Device2020-12-09Class II
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Ethicon, Inc.
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.
Sold states
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.
Affected count
295 units distributed. Only 15 units are being recalled.
Manufactured in
Us Highway 22 West, N/A, Somerville, NJ, United States
Products
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0533-2021Don't want to check this manually?
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