Recall Z-0903-2011 ยท FTL Mesh, Surgical, Polymeric
Ethicon, Inc.
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.
| Date | Jan 14, 2011 (initiated Oct 18, 2010) |
| Status | Open, Classified |
| Reason | There is a potential for delamination in one lot of Proceed surgical mesh. |
| Root cause | 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 p |
| Quantity | 87 products |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060713 | PROCEED SURGICAL MESH ETHICON, Inc., May 25, 2006 |