| Class 2 Device Recall |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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