Ethicon, Inc.: PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm

Recall number

Z-0533-2021

Recalling firm

Ethicon, Inc.

Product

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

Status

Terminated

Initiated

2020-10-23

Posted

not on file

Terminated

2022-12-21

Reason

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.

Root cause

Under Investigation by firm

Action

Note: This recall is specific to this single lot of PROCEED Surgical Mesh. Health care practitioners who have treated patients using this product should follow those patients post-operatively in the usual manner with no additional action required. Product subject to the recall in your inventory can be identified by the product code information described in the above table. all unused PROCEED Surgical Mesh subject to this recall are required to be returned. Please utilize attachment 1 for assistance in identifying the product lots subject to this recall. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (Attachment 2) confirming receipt of this notice and return to Ethicon sales representative or distributor by [INSERT DATE]. Please return the Business Reply Form even if you do not have products subject to this recall. 5. Follow instructions in the letter and immediately return unused impacted PROCEED Surgical Mesh subject to this recall to Ethicon sales representative or distributor. To receive credit reimbursement, customers must return product subject to this recall. Any non-affected product and any product returned after the date specified will not receive credit. 6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Ethicon Korea. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your re

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.

Lot, serial or model codes

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

510(k) numbers

["K060713"]

PMA numbers

not on file

Product code

FTL

Firm FEI

2210968

Firm city

Somerville

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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