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PROCEED Surgical Mesh recallZ-0903-2011 · Ethicon, Inc. · initiated Oct 18, 2010

Open, Classified All recalls posted in January 2011

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

There is a potential for delamination in one lot of Proceed surgical mesh.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0903-2011
Recall class
Not yet classified by the FDA
Status
Open, Classified
Initiated by the company
Oct 18, 2010
Posted by the FDA
Jan 14, 2011
Recalling firm
Ethicon, Inc.
Quantity
87 products
Product code
FTL
FDA submissions
K060713
Distribution
Worldwide Distribution

Product description

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.

Code information (models, lots, serial numbers)

Product code PCDG1, Lot number BMG618.

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

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