PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial de
FDA device recall Z-0449-06 · posted 2006-01-26 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc.
- Reason for recall
- 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.
- Action taken
- The recall was initiated on 12/21/2005. The recall to the customers were initiate via letter with return receipt on 1/4/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 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 countrie
- Date initiated
- 2006-01-04
- Date posted
- 2006-01-26
- Date terminated
- 2006-09-28
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROCEED TRILAMINATE SURGICAL MESH (K031925) | ETHICON, Inc. | 2003-09-17 |