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U.S. Department of Health and Human Services

Class 2 Device Recall PROCEED Surgical Mesh

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  Class 2 Device Recall PROCEED Surgical Mesh see related information
Date Initiated by Firm October 18, 2010
Date Posted January 14, 2011
Recall Status1 Open3, Classified
Recall Number Z-0903-2011
Recall Event ID 57021
510(K)Number K060713  
Product Classification Polymeric Surgical Mesh - Product Code FTL
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.
Code Information Product code PCDG1, Lot number BMG618.
Recalling Firm/
Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact Ms. Christiana Bielinski
Manufacturer Reason
for Recall
There is a potential for delamination in one lot of Proceed surgical mesh.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = ETHICON INC.