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Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1 recallZ-1329-2014 · Ethicon, Inc. · initiated Feb 19, 2014

Class II Open, Classified All recalls posted in April 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1329-2014
Recall class
Class II
Status
Open, Classified
Initiated by the company
Feb 19, 2014
Posted by the FDA
Apr 3, 2014
Recalling firm
Ethicon, Inc.
Quantity
223 units
Product code
FTM
FDA submissions
K060713
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 description

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.

Code information (models, lots, serial numbers)

Product Code PCDB1 - Lot number - GGG157 Product Code PCDT1 - Lot number - GGG158 Product Code PCDJ1 - Lot number -GGG159

Other devices under the same FDA submission

11 devices cleared under K060713 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page