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U.S. Department of Health and Human Services

Class 2 Device Recall ELECTROLASE HYFRECATOR(R) ELECTRODES SHARP

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 Class 2 Recall
ELECTROLASE HYFRECATOR(R) ELECTRODES SHARP
see related information
Date Posted February 15, 2013
Recall Status1 Open
Recall Number Z-0826-2013
Recall Event ID 64248
Premarket Notification
510(K) Number
K800617 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
Code Information Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].
Recalling Firm/
Manufacturer
ConMed Corporation
525 French Road
Utica, New York 13502
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Equipment Maintenance
Action ConMed sent Urgent Device Recall Letters (dated 1/28/13) and Business Reply Forms to all domestic customers via USPS Priority Mail. International notices were sent via FedEx International Priority to the foreign consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and complete Attachment II response form and return it with unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502. Customers were asked to return Attachment II even if they don't have any affected product. For questions regarding this recall call 315-624-3533.
Quantity in Commerce Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.
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 = BIRTCHER CORP.
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