Z-1329-2014Class II

Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH...

Name: Z-1329-2014 Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH...
Creator: Ethicon, Inc.
Published: 2014-02-19
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2014-02-19 / Open, Classified / root cause: packaging

FDA source

Ethicon, Inc. began a recall of Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial... on 2014-02-19. FDA classified it as Class II and gives the reason as "The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1329-2014
Classification: Class II
Status: Open, Classified
Initiated: 2014-02-19
Posted: 2014-04-03
Recalling firm: Ethicon, Inc
Product: Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, 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: FTM Mesh, Surgical
Reason for recall: The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Ethicon sent an Urgent Medical Device Recall letter dated February 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine their inventory and determine if they have any of the affected product. If any product has been distributed, those hospitals should be notified. The business reply form should be completed and faxed or emailed to Stericycle at 1-888-641-9732 or [email protected]. For clinical or product support contact a customer representative or call the Customer Support Center at 1-877-ETHICON to speak with a registered nurse or contact Stericycle at 1-888-345-0524 and reference event #5798. Stericycle is handling returns.
Quantity in commerce: 223 units
Distribution: US Distribution including the states of FL, NJ, MO, IL, PA, NC. TX, TN, WA, ID, UT, WV, MS. CA, AL, MA. GA, LA and OK.
Product codes and lots: Product Code PCDB1 - Lot number - GGG157 Product Code PCDT1 - Lot number - GGG158 Product Code PCDJ1 - Lot number -GGG159

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1329-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1329-2014	Class II	Ongoing	Voluntary: Firm initiated	2014-04-09	2014-04-03

Product code FTM

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)