Events

Recall of Device Recall ConMed ALTRUS Thermal Tissue Fusion System

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
    72586
  • Event Risk Class
    Class 2
  • Event Number
    Z-0359-2016
  • Event Initiated Date
    2015-11-05
  • Event Date Posted
    2015-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141613
  • 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
    Miscalibration of the energy source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. this causes some devices to generate a "check seal" message with an audible alarm and to stop the heating cycle.
  • Action
    On November 4, 2015, ConMed Corporation distributed Urgent Device Recall Notification letters dated November 5, 2015 to their customers via overnight courier service. Customers should stop the use of these devices immediately. The recall notice recipient should contact all organizations within their facility and any other facilities that may have received the affected products. It is imperative that all end users of these devices receive this notice and respond immediately. Customers with questions can call Patricia Cotter, ConMed Recall Coordinator 315-624-3237 (8AM - 5PM EST, Monday through Friday), or fax to 315-624-3225 or email altrus@conmed.com. Customers who have any of the devices subject to recall (listed on the recall notice-attachment I) should immediately contact their sales representative. The sales representative will deliver a replacement unit to your facility and will pick up and return the recalled devices to ConMed Corporation. If you are unable to reach your sales representative, please contact Patricia Cotter at the numbers above. If you do not have any devices to return, customers should complete the Business Reply Form (attachment II), indicating you have no devivces and fax it to 315-624-3225, Attn: Patricia Cotter.

Device

Device Recall ConMed ALTRUS Thermal Tissue Fusion System
  • Model / Serial
    Serial Numbers: 1) 15090103 & 15150005, 15150006, 15150007, 15150008, 15150009, 15150010, 15150011, 15150012, 15130004, 15250013, 15250014, 15250015, 15250016, 15250017, 15300018 & 15300020, 2) 15050001, 15300005 & 15300006
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, and TX and in the country of Mexico.
  • Product Description
    Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Manufacturer Address
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA