Class 2 Device Recall Electrosurgical generator.

• Date Initiated by Firm: December 27, 2010
• Date Posted: February 17, 2011
• Recall Status: Terminated on August 01, 2011
• Recall Number: Z-1362-2011
• Recall Event ID: 57544
• 510(K)Number: K052009
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: ConMed System 2450 Electrosurgical Generator, REF 60-2450-100, 100 V, ConMed Electrosurgery, Centennial, CO. A general-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of high (HF) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site
• Code Information: Serial numbers: 09AGU111, 09AGU112, 09AGU113, 09AGU114, 09AGU115, 09AGU116, 08FGU100, 08FGU101, 08FGU102, 08FGU103, 08FGU104, 08FGU105, 08FGU106, 08FGU107, 08FGU108, 08FGU109, 08GGU001, 08GGU002, 08GGU003, 08GGU004, 08GGU005, 08GGU006, 08GGU007, 08GGU008, 08GGU009, 08GGU010, 08GGU011, 08GGU012, 08GGU013, 08GGU014, 08GGU015, 08GGU016, 08GGU017, 08GGU018, 08GGU019, 08GGU020, 08GGU021, 08GGU022, 08GGU023, 08GGU024, 08GGU025, 08GGU026, 08GGU027, 08GGU028, 08KGU071, 08KGU072, 08KGU073, 08KGU074, 08KGU075, 08KGU076, 08KGU077, 08KGU078, 08KGU079, 08KGU080, 08KGU081, 08KGU082, 08KGU083, 08KGU084, 08KGU085, 08KGU086, 08KGU087, 08KGU088, 08KGU089, 08KGU090, 08LGU001, 08LGU002, 08LGU003, 08LGU004, 08LGU005, 08LGU006, 08LGU007, 08LGU008, 08LGU009, 08LGU010, 08LGU011, 08LGU012, 08LGU013, 08LGU014, 08LGU015, 08LGU016, 08LGU017, 08LGU018, 08LGU019, 08LGU020, 09BGU081, 09BGU082, 09BGU083, 09BGU084, 09CGU001, 09CGU002, 09CGU003, 09CGU004, 09CGU005, 09CGU006, 09CGU007, 09CGU008, 09CGU009, 09CGU010, 09CGO090, 09CGU096, 09CGU097, 09CGU098, 09CGU099, 09CGU100, 09CGU101, 09CGU102, 09CGU103, 09CGU104, 09CGU105, 09CGU106, 09CGU107, 09CGU108, 09CGU109, 09CGU110, 09DGU031, 09DGU032, 09DGU033, 09DGU034, 09DGU035.
• Recalling Firm/ Manufacturer: ConMed Electrosurgery; 14603 E Fremont Ave; Centennial CO 80112-4251
• For Additional Information Contact: 303-269-8294
• Manufacturer Reason for Recall: Electrosurgical generator may allow possibility of electrical shock and/or burns to user or patient.
• FDA Determined Cause: Device Design
• Action: ConMed Electrosurgery sent an Urgent Device Recall letter dted December 27, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify anyone who may have received the affected product.. They were to review their inventory and return a Business Reply Form via fax to 303-699-9854 and to contact ConMed Electrosurgery Technical Services at 800-552-0138 to schedule a time to have their equipment upgraded.
• Quantity in Commerce: 119 units
• Distribution: Worldwide Distribution, including USA (nationwide) and the countries of Australia, Belgium, Bolivia, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Honduras, Hong Kong, Hungary, India, Iraq, Israel, Italy, Jamaica, Japan, Jordan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, Vietnam.
• 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