Z-0533-2021Class II

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

Name: Z-0533-2021 PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Creator: Ethicon, Inc.
Published: 2020-10-23
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2020-10-23 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm on 2020-10-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0533-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-23
Posted: 2020-12-03
Terminated: 2022-12-21
Recalling firm: Ethicon, Inc
Product: PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: Product Code - PCDG1 Product Lot - PHG118 GTIN Code - 10705031047716 Expiration Date: 07/31/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0533-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0533-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-03

Product code FTL

K060713Class IIProceed Surgical MeshETHICON, Inc. / cleared 2006-05-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)