Events

Recall of Hyfrecator 2000

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
    27659
  • Event Risk Class
    Class 2
  • Event Number
    Z-0144-04
  • Event Initiated Date
    2003-09-15
  • Event Date Posted
    2003-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30290
  • 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 hyfrecator 2000 units were released without documented adherence to their voltage output specification.
  • Action
    All customers were notified by certified letter on 9/15/03. Mailing to the Phillipines by registered mail also on 9/15/03. Firm requests that the units be returned for testing or the replacement with another unit.

Device

Hyfrecator 2000
  • Model / Serial
    Serial numbers: 01AGJ199, 01AGJ262, 01DGJ251, 01EGJ125, 01JGJ177, 01MGJ243, 02CGJ244, 02EGJ160, 02EGJ311 and 02LGJ211.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Units were distributed to CA, CT,IL and ME. International distribution to Phillipines.
  • Product Description
    Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230.
  • Manufacturer
    ConMed Electrosurgery

Manufacturer

ConMed Electrosurgery
  • Manufacturer Address
    ConMed Electrosurgery, 7211 S Eagle St, Centennial CO 80112-4203
  • Source
    USFDA