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U.S. Department of Health and Human Services

Class 2 Device Recall Electrosurgery Accessory Electrodes

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 Class 2 Recall
Electrosurgery Accessory Electrodes
see related information
Date Posted December 11, 2007
Recall Status1 Terminated on March 31, 2010
Recall Number Z-0452-2008
Recall Event ID 45867
Premarket Notification
510(K) Numbers
K935091  K991855 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - 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, Colorado 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = CONMED CORP.
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