Events

Recall of Device Recall Flexxus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Conmed Endoscopic Technologies, Inc..

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
    37628
  • Event Risk Class
    Class 2
  • Event Number
    Z-0730-2007
  • Event Initiated Date
    2007-03-14
  • Event Date Posted
    2007-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51134
  • 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
    Endoscopic Biliary Stent, - Product Code FGE
  • Reason
    Blue safety clip incorrectly placed on the stent may prevent deployment.
  • Action
    ConMed Endoscopic Technologies notified consignes by letter dated 3/14/07 requesting them to return recalled devices.

Device

Device Recall Flexxus
  • Model / Serial
    Lot Number: ANQJ0639
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution, USA including states of DE, OH, MI, DC and countries of Belgium Japan.
  • Product Description
    Flexxus™ Endoscopic Biliary Stent, 7.5 Fr || 10 mm diameter x 60 mm length || Item Number: LXB10060
  • Manufacturer
    Conmed Endoscopic Technologies, Inc.

Manufacturer

Conmed Endoscopic Technologies, Inc.
  • Manufacturer Address
    Conmed Endoscopic Technologies, Inc., 129 Concord Rd Bldg 3, Billerica MA 01821-4600
  • Source
    USFDA