Events

Recall of Zilver Expandable Metal Biliary Stent System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Endoscopy.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49518
  • Event Risk Class
    Class 2
  • Event Number
    Z-0113-2009
  • Event Initiated Date
    2008-09-11
  • Event Date Posted
    2008-10-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73715
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stent - Product Code FGE
  • Reason
    A section of the introduction system may detach after the stent has deployed.
  • 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.

Device

Zilver Expandable Metal Biliary Stent System
  • Model / Serial
    Lot number W2528796
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA: IL and OUS: China
  • Product Description
    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.
  • Manufacturer
    Cook Endoscopy

Manufacturer

Cook Endoscopy
  • Manufacturer Address
    Cook Endoscopy, 4900 Bethania Station Rd, Winston Salem NC 27105-1203
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA