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
    67610
  • Event Risk Class
    Class 2
  • Event Number
    Z-1839-2014
  • Event Initiated Date
    2014-02-20
  • Event Date Posted
    2014-06-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125832
  • 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
    Conmed corporation initiated an urgent medical device correction for altrus thermal tissue fusion handpieces due to risk of burns.
  • Action
    On February 20, 2014 and February 28, 2014 ConMed Corporation distributed Urgent Medical Device Correction notices to their domestic and foreign customers via FedEx Priority. The notice was generated by ConMed for information purposes only. Customers are to ensure that the jaws of the energy vessel sealing device does not come in contact with unintended tissue, surfaces, or objects until the jaws have cooled sufficiently. Customers who have further distributed this product, please forward a copy of the correction notice to the recipient as appropriate. Customers will questions should contact ConMed Regulatory Affairs at (315) 624-3237 or by email at altrus@conmed.com.

Device

Device Recall ConMed ALTRUS Thermal Tissue Fusion System
  • Model / Serial
    all lot codes
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36 cm Catalog Number 60-9522-001. Products are packaged within cartons, 6 units per carton.
  • Manufacturer
    ConMed Corporation

Manufacturer

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