Recall Z-0449-06 ยท FTL Mesh, Surgical, Polymeric
Ethicon, Inc.
PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while
| Date | Jan 26, 2006 (initiated Jan 4, 2006) |
| Status | Terminated |
| Reason | Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization. |
| Root cause | Other |
| Action | The recall was initiated on 12/21/2005. The recall to the customers were initiate via letter with return receipt on 1/4/2006. |
| Quantity | 18,270 devices |
| Distribution | There is a total of 1,070 consignees that have received recall product divided between hospitals and distributors nationwide. The product has been distributed internationally to the following countries: Argentina, Australia, Austra, Brazil, Canada, Chile Colombia, Czechoslovakian Republic, France, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031925 | PROCEED TRILAMINATE SURGICAL MESH ETHICON, Inc., Sep 17, 2003 |