Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System:
FDA device recall Z-0113-2009 · posted 2008-10-14 · Terminated
Recall details
- Recalling firm
- Cook Endoscopy
- Reason for recall
- A section of the introduction system may detach after the stent has deployed.
- Action taken
- The consignee was notified by letter on/about 09/11/2008. The distributor was instructed to contact their customers and coordinate the return of all affected product to Cook Endoscopy. A responds form was attached to the letter to be completed and returned to Cook Medical to confirm receipt of notification and indicate quantity to be returned. Contact Cook Endoscopy at 1-336-744-0157, ext. 6325 for assistance.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 12
- Distribution
- USA: IL and OUS: China
- Date initiated
- 2008-09-11
- Date posted
- 2008-10-14
- Date terminated
- 2009-04-01
- Location
- Winston Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WILSON-COOK ZILVER BILIARY STENT (K020788) | Wilson-Cook Medical, Inc. | 2002-05-08 |