Class 2 Device Recall Hyfrecator 2000

• Date Initiated by Firm: September 15, 2003
• Date Posted: November 19, 2003
• Recall Status: Terminated on July 01, 2004
• Recall Number: Z-0144-04
• Recall Event ID: 27659
• 510(K)Number: K970493
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230.
• Code Information: Serial numbers: 01AGJ199, 01AGJ262, 01DGJ251, 01EGJ125, 01JGJ177, 01MGJ243, 02CGJ244, 02EGJ160, 02EGJ311 and 02LGJ211.
• FEI Number: 3004491689
• Recalling Firm/ Manufacturer: ConMed Electrosurgery; 7211 S Eagle St; Centennial CO 80112-4203
• For Additional Information Contact: Charles M. Hart; 303-699-7600 Ext. 5238
• Manufacturer Reason for Recall: The Hyfrecator 2000 units were released without documented adherence to their voltage output specification.
• FDA Determined Cause: Other
• Action: All customers were notified by certified letter on 9/15/03. Mailing to the Phillipines by registered mail also on 9/15/03. Firm requests that the units be returned for testing or the replacement with another unit.
• Quantity in Commerce: 10 units
• Distribution: Units were distributed to CA, CT,IL and ME. International distribution to Phillipines.
• 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