Events

Recall of Device Recall Altrus Thermal Tissue Fusion

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
    61821
  • Event Risk Class
    Class 2
  • Event Number
    Z-1680-2012
  • Event Initiated Date
    2012-05-07
  • Event Date Posted
    2012-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109175
  • 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 devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
  • Action
    ConMed Electrosurgery sent an "URGENT: DEVICE RECALL" letter dated May 2, 2012 to all affected customers. The letter identifies the product, problem,and actions to be taken by the customers. The letter instructs customers to review their inventory and to complete and return a Business Reply Form via fax to 303-699-9854.

Device

Device Recall Altrus Thermal Tissue Fusion
  • Model / Serial
    Lot codes: 11DHB004, 11AHB001, 11AHB006.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC, MD, CT, NJ, and CA.
  • Product Description
    Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 23 cm Shaft, Catalog Number 60-9521-001, Sterile/ EO. || The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece.
  • 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