Z-0113-2009

Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm...

Name: Z-0113-2009 Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm...
Creator: Cook Endoscopy
Published: 2008-09-11
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2008-09-11 / Terminated / root cause: manufacturing process

FDA source

Cook Endoscopy began a recall of Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx... on 2008-09-11. The reason FDA records is "A section of the introduction system may detach after the stent has deployed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0113-2009
Status: Terminated
Initiated: 2008-09-11
Posted: 2008-10-14
Terminated: 2009-04-01
Recalling firm: Wilson-Cook Medical Inc.
Product: Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, NC. The device is used in palliation neoplasms in the biliary tree.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: A section of the introduction system may detach after the stent has deployed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 12
Distribution: USA: IL and OUS: China
Product codes and lots: Lot number W2528796

Product code FGE

K020788Class IIWilson-Cook Zilver Biliary StentWilson-Cook Medical, Inc. / cleared 2002-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)