Events

Recall of Device Recall ELECTROLASE HYFRECATOR(R) ELECTRODES SHARP

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

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
    64248
  • Event Risk Class
    Class 2
  • Event Number
    Z-0826-2013
  • Event Initiated Date
    2013-01-28
  • Event Date Posted
    2013-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115662
  • 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
    Some devices had broken through the seal of the sterile pouch. conmed confirmed instances where the pouch seal was compromised on the affected products.
  • Action
    ConMed sent Urgent Device Recall Letters (dated 1/28/13) and Business Reply Forms to all domestic customers via USPS Priority Mail. International notices were sent via FedEx International Priority to the foreign consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and complete Attachment II response form and return it with unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502. Customers were asked to return Attachment II even if they don't have any affected product. For questions regarding this recall call 315-624-3533.

Device

Device Recall ELECTROLASE HYFRECATOR(R) ELECTRODES SHARP
  • Model / Serial
    Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.
  • Product Description
    ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. || Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Manufacturer Address
    ConMed Corporation, 525 French Road, Utica NY 13502
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA