Events

Recall of Device Recall Electrosurgery Accessory Electrodes

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

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
    45867
  • Event Risk Class
    Class 2
  • Event Number
    Z-0452-2008
  • Event Initiated Date
    2007-11-02
  • Event Date Posted
    2007-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66304
  • 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
    Electrosurgery Accessory Electrodes - Product Code GEI
  • Reason
    Sterility (package integrity) compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal.
  • Action
    Consignees were notified by Urgent Voluntary Device Recall letter on 11/02/2007, from ConMed Corporation. They were asked to return affected product for replacement.

Device

Device Recall Electrosurgery Accessory Electrodes
  • Model / Serial
    Part Numbers: 138100, 138101, 138102, 138103, 138104, 138105, 138107, 138110, 138112, 138113, 139100, 139107, 139108, 139112, 139321, 139104EXT, 139105EXT, 139110EXT, 139112EXT. LOT CODES: 0706211 through 0709201.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA and countries of Australia, Canada, China, Belgium, Chile, Denmark, Ecuador, France, Greece, India, Israel, Italy, Japan, Korea, Mexico, New Zealand, Norway, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, and Uruguay.
  • Product Description
    Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Conmed Corporation, Utica, New York 13502.
  • Manufacturer
    ConMed Electrosurgery

Manufacturer

ConMed Electrosurgery
  • Manufacturer Address
    ConMed Electrosurgery, 14603 E. Fremont Avenue, Centennial CO 80112
  • Source
    USFDA