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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 August 09, 2004
Date Posted August 28, 2004
Recall Status1 Terminated 3 on October 05, 2005
Recall Number Z-1413-04
Recall Event ID 29821
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) as follows:

Cat. #60-5158-034 - Spatula, 5 mm x 32 cm;
Cat #60-5158-432 - ''L'' Hook 5 mm x 32 cm;
Cat #60-5158-934 - Needle 5mm x 32 cm; Firm on label: ConMed Corporation, Utica, New York 13502.
Code Information Cat #60-5158-034, Lot #s 0309121;  Cat #60-5158-432, Lot #s 0308071, 0309021, 0309151, 1121;  Cat #60-5158-934, Lot #s 0309111; 
Recalling Firm/
Manufacturer		 Conmed Corporation
525 French Rd
Utica NY 13502-5945
For Additional Information Contact Linda Whittemore
315-765-8365
Manufacturer Reason
for Recall		 Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.
FDA Determined
Cause 2		 Other
Action Letters dated 8/9/04 via Priority Mail with instructions to return product and subrecall if further distributed.
Quantity in Commerce 1,005 units
Distribution There are 127 distributors, hospitals and sales representatives in the U.S. There are 21 foreign consignees in Australia, Brazil, Canada, Costa Rica, Ecuador, Finland, India, Israel, Italy, Norway, Peru, Saudi Arabia, Spain, Turkey, United Kingdom, and Venezuela.
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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