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U.S. Department of Health and Human Services

Class 2 Device Recall MACROLYTE

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 Class 2 Recall
MACROLYTE
see related information
Date Posted June 04, 2014
Recall Status1 Open
Recall Number Z-1719-2014
Recall Event ID 68193
Premarket Notification
510(K) Number
K120476 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
Code Information Beginning Lot Code 1204275; Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds, where s is the shift).
Recalling Firm/
Manufacturer
ConMed Corporation
525 French Rd
Utica, New York 13502-5945
For Additional Information Contact Roger B. Murphy
727-399-5205
Manufacturer Reason
for Recall
ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action ConMed sent an Urgent Medical Device Recall letter dated May 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Corrective Action: All returned devices will be received into the facility and the lot number and quantity recorded on to an electronic spreadsheet. The returned product will then be stored in a secure quarantined area. At this time, management has not determined as to how the devices will be dispositioned. A protocol(s) will be written to address the destruction of the returned devices. This will be submitted to NYK-DO for approval prior to any action being taken with the returned devices. CAPA 153136 was opened. Fixtures were revised to allow for placement of the foil/gel substrate from the bottom of the foam. This is to maintain consistent dimensions on the product and not allow for float/movement of the substrate from being offset. For further questions please call (315) 624-3024 or fax to (315) 624-3030.
Quantity in Commerce Domestic - 12,600 units, Foreign - 44,280 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Ecuador, El Salvador, Finland, France, Great Britain, Honduras, India, Indonesia, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Mexico, Panama, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, United Arab Emirates and Uruguay.
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 = CONMED CORPORATION
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