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.
Recall
- Recall Number
- Z-0903-2011
- Event Number
- 57021
- Firm
- Ethicon, Inc. US
- FEI Number
- 2210968
- Product Code
- FTL
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 18, 2010
- Posted
- January 14, 2011
- Address
- Highway 22 West, Somerville, NJ, 08876
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.
There is a potential for delamination in one lot of Proceed surgical mesh.
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.
Worldwide Distribution
87 products