PROCEED Surgical Mesh; Product Code PCDG1; :Lot BMG618; Ethicon, Inc. a Johnson & Johnson Company. Used for the repair o
FDA device recall Z-0903-2011 · posted 2011-01-14 · Open, Classified
Recall details
- Recalling firm
- Ethicon, Inc.
- Reason for recall
- There is a potential for delamination in one lot of Proceed surgical mesh.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- FTL
- Quantity affected
- 87 products
- Distribution
- Worldwide Distribution
- Date initiated
- 2010-10-18
- Date posted
- 2011-01-14
- 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 SURGICAL MESH (K060713) | ETHICON, Inc. | 2006-05-25 |