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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmAugust 09, 2004
Date PostedAugust 28, 2004
Recall Status1 Terminated 3 on October 05, 2005
Recall NumberZ-1413-04
Recall Event ID 29821
510(K)NumberK960808 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
ProductConMed 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; 
FEI Number 3001451571
Recalling Firm/
Manufacturer		 Conmed Corporation
525 French Rd
Utica NY 13502-5945
For Additional Information ContactLinda 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
ActionLetters dated 8/9/04 via Priority Mail with instructions to return product and subrecall if further distributed.
Quantity in Commerce1,005 units
DistributionThere 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 CycleTPLC 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) Database510(K)s with Product Code = GEI
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