FDAClass IIDecember 9, 2020

PROCEED Surgical Mesh Hernia Mesh Oval recall

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

Why was PROCEED Surgical Mesh Hernia Mesh Oval recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code - PCDG1 Product Lot - PHG118 GTIN Code - 10705031047716 Expiration Date: 07/31/2021

Product
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Recalling firm
Ethicon, Inc.
Quantity
295 units distributed. Only 15 units are being recalled.
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.
Recall date
December 9, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls