Z-0903-2011

PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company. Used for...

Name: Z-0903-2011 PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company. Used for...
Creator: Ethicon, Inc.
Published: 2010-10-18
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2010-10-18 / Open, Classified / root cause: manufacturing process

FDA source

Ethicon, Inc. began a recall of PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company. Used for the repair of hernias and other fascial... on 2010-10-18. The reason FDA records is "There is a potential for delamination in one lot of Proceed surgical mesh". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0903-2011
Status: Open, Classified
Initiated: 2010-10-18
Posted: 2011-01-14
Recalling firm: Ethicon, Inc
Product: PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company. Used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: There is a potential for delamination in one lot of Proceed surgical mesh.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Ethicon sent Urgent Voluntary Product Recall letters via Fed Ex on October 18, 2010. The letters described the issue with the affected product and instructed customers not to use it. They are to immediately remove the recalled product from their inventory and return it according to the instructions provided. A reply card is attached and must be filled out and returned to Stericycle whether or not the customer has product in their possession. Separate correspondence has been sent to end customers stating that if they have purchased the recalled product through a distributor, to return the product directly to Stericycle. Replacement product will be provided at no additional charge for all recalled product.
Quantity in commerce: 87 products
Distribution: Worldwide Distribution
Product codes and lots: Product code PCDG1, Lot number BMG618.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)