Events

Recall of Device Recall ABC BendABEAM Handpiece,134006

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
    52030
  • Event Risk Class
    Class 2
  • Event Number
    Z-2277-2010
  • Event Initiated Date
    2008-12-18
  • Event Date Posted
    2010-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89828
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    The internal electrode protrudes in front of the ceramic insulator tip of the handpiece.
  • Action
    An Urgent Device Recall notification was issued 12/18/2008, which explained the problem/risk associated with the device, the discontinuance of use and the return of the device. If you have any questions, please contact 800-552-0138, ext. 5225.

Device

Device Recall ABC BendABEAM Handpiece,134006
  • Model / Serial
    Lot: 0306021 through 0806021
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and International
  • Product Description
    ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 cm) QTY: 1 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (Pouch label) || ABC Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6" (15.2 cm) QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13205 ASSEMBLED IN MEXICO (case label) || Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.
  • Manufacturer
    ConMed Electrosurgery

Manufacturer

ConMed Electrosurgery
  • Manufacturer Address
    ConMed Electrosurgery, 14603 E Fremont Ave, Centennial CO 80112-4251
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA