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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 28, 2004
Date Posted July 31, 2004
Recall Status1 Terminated 3 on October 05, 2005
Recall Number Z-1301-04
Recall Event ID 29478
510(K)Number K960808  
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle. FIRM ON LABEL: ConMed Corporation, Utica, New York, USA 13502.
Code Information Cat. #60-5158-034 with lot #s 0310301, 0402031, 0403051, 0404131;  Cat. # 60-5158-234 with lot # 0310081;  Cat. #60-5158-432 with lot #s 0310081, 0310301, 0311101, 0401051, 0401121, 0402031, 0403051, 0411121;  Cat. # 60-5158-934 with lot #s 0311101, 0401121.
Recalling Firm/
Manufacturer
Conmed Corporation
525 French Rd
Utica NY 13502-5945
For Additional Information Contact Linda Whittemore
800-765-8365 Ext. 3059
Manufacturer Reason
for Recall
Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. There is potential for electrical shock.
FDA Determined
Cause 2
Other
Action Letters dated 6/28/04 via Priority Mail with instructions to return product and to subrecall if further distributed.
Quantity in Commerce 3,252 units
Distribution Nationwide distribution to 24 hospitals, 3 distributors and 13 sales reps. Six foreign consignees in Mexico, Italy, United Kingdom, Spain, Turkey and Australia.
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.
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