Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ConMed ALTRUS Thermal Tissue Fusion System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ConMed ALTRUS Thermal Tissue Fusion System see related information
Date Initiated by Firm November 05, 2015
Date Posted December 01, 2015
Recall Status1 Terminated 3 on May 24, 2018
Recall Number Z-0359-2016
Recall Event ID 72586
510(K)Number K140459  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
Code Information Serial Numbers: 1) 15090103 & 15150005, 15150006, 15150007, 15150008, 15150009, 15150010, 15150011, 15150012, 15130004, 15250013, 15250014, 15250015, 15250016, 15250017, 15300018 & 15300020, 2) 15050001, 15300005 & 15300006
Recalling Firm/
Manufacturer		 ConMed Corporation
525 French Rd
Utica NY 13502-5945
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 9 devices
Distribution Distributed in the states of CA, and TX and in the country of Mexico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = CONMED CORPORATION
-
-