Z-0089-04

ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts...

Name: Z-0089-04 ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts...
Creator: Wilson-Cook Medical Inc
Published: 2002-08-21
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2002-08-21 / Terminated

FDA source

Wilson-Cook Medical Inc began a recall of ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR... on 2002-08-21. The reason FDA records is "Complaints were reported of difficulty in stent deployment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0089-04
Status: Terminated
Initiated: 2002-08-21
Posted: 2003-11-06
Terminated: 2003-12-11
Recalling firm: Wilson-Cook Medical Inc.
Product: ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Complaints were reported of difficulty in stent deployment.
FDA root cause: Other
Action: Sales representatives were sent notices via email on April 21, 2002. They were responsible for visiting each of their accounts, inform them of the Market Withdrawal and to return the device for replacement.
Quantity in commerce: 155 units
Distribution: The device was distributed nationwide, Ireland and Jordan.
Product codes and lots: Catalog number: ZILBS-10-4, ZILBS-6-4, ZILBS-8-4, ZILBS-10-6, ZILBS-6-6, ZILBS-8-6, ZILBS-10-8, ZILBS-6-8, ZILBS-8-8, Lot number: 1616783, 1616787, 1622794, 1622798, 1622802, 166958, 1622966, 162970, 162993, 1623007, 1623016, 1626424, 1631805, 1616784, 1616788, 1622795, 1622799, 1622803, 1622959, 1622803, 1622959, 1622963, 1622967, 1622982, 1622994, 1623008, 1623017, 1631388, 1633707, 1616785, 1616789, 1622796, 1622800, 1622804, 1622960, 1622964, 1622968, 1622985, 1623001, 1623009, 1623018, 1631803, 1634239, 1616786, 1616790, 1622797, 1622801, 1622956, 1622961, 1622965, 1622969, 1622986, 1623002, 1623015, 1626423, 1631804, 1635626.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)