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
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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/ Manufacturer |
Ethicon, Inc. US Highway 22 West Somerville NJ 08876
|
For Additional Information Contact | Ms. Christiana Bielinski 908-218-0707 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = FTL
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