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 Electrosurgery Accessory Electrodes

  • 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 Electrosurgery Accessory Electrodes see related information
Date Initiated by Firm November 02, 2007
Date Posted December 11, 2007
Recall Status1 Terminated 3 on March 31, 2010
Recall Number Z-0452-2008
Recall Event ID 45867
510(K)Number K991855  K935091  
Product Classification Electrosurgery Accessory Electrodes - Product Code GEI
Product Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Conmed Corporation, Utica, New York 13502.
Code Information Part Numbers: 138100, 138101, 138102, 138103, 138104, 138105, 138107, 138110, 138112, 138113, 139100, 139107, 139108, 139112, 139321, 139104EXT, 139105EXT, 139110EXT, 139112EXT. LOT CODES: 0706211 through 0709201.
Recalling Firm/
Manufacturer		 ConMed Electrosurgery
14603 E. Fremont Avenue
Centennial CO 80112
For Additional Information Contact Shawn Riedel
303-269-8224
Manufacturer Reason
for Recall		 Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal
FDA Determined
Cause 2		 Process design
Action Consignees were notified by Urgent Voluntary Device Recall letter on 11/02/2007, from ConMed Corporation. They were asked to return affected product for replacement.
Quantity in Commerce 11,319 cases (476,160 units)
Distribution Worldwide: USA and countries of Australia, Canada, China, Belgium, Chile, Denmark, Ecuador, France, Greece, India, Israel, Italy, Japan, Korea, Mexico, New Zealand, Norway, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, and Uruguay.
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 CORP.
-
-