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U.S. Department of Health and Human Services

Class 2 Device Recall Altrus Energy Source

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 Class 2 Recall
Altrus Energy Source
see related information
Date Posted May 29, 2012
Recall Status1 Terminated on June 19, 2012
Recall Number Z-1678-2012
Recall Event ID 61814
Premarket Notification
510(K) Number
K101534 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source ConMed Corporation 525 French Rd, Utica, NY 13502, MDSS GmbH, Germany. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece.
Code Information 11AGZ003, 10KGZ001, 10MGZ001, 10MGZ003, 10MGZ004, 11AGZ001, 11AGZ002, 11AGZ003, 11AGZ004, 11AGZ006, 11AGZ007, 11BGZ001, 11BGZ002, 11BGZ003, 11DGZ001, 11DGZ002, 11DGZ003, 11DGZ004, 11DGZ005, 11DGZ006, 11DGZ007, 11DGZ008, 11DGZ009, 11DGZ010, 11DGZ011, 11DGZ012, 11DGZ013, 11DGZ014, 11DGZ015, 11DGZ016, 11DGZ017, 11DGZ018, 11FGZ001, 11FGZ002, 11FGZ003, 11FGZ005, 11FGZ006, 11FGZ007, 11FGZ008, 11GGZ001, 11GGZ002, 11GGZ003, 11GGZ004, 11GGZ006, 11GGZ007, 11GGZ008, 11GGZ009, 11HGZ001, 11HGZ002, 11HGZ003, 11HGZ005, 11HGZ007, 11HGZ008, 11HGZ009, 11HGZ010, 11HGZ011, 11HGZ012, 11HGZ013, 11HGZ014, 11HGZ015, 11HGZ016, 11HGZ017, 11HGZ018, 11HGZ019, 11HGZ020, 11HGZ021, 11HGZ022, 11HGZ023, 11HGZ024, 11HGZ025, 11HGZ026, 11HGZ027, 11JGZ001, 11JGZ002, 11JGZ003, 11JGZ004, 11KGZ001, 11KGZ002, 11KGZ003, 11KGZ004, 11KGZ005, 11KGZ006, 11KGZ007, 11KGZ008, 11KGZ009, 11KGZ010, 11KGZ011, 11KGZ012, 11KGZ013, 11KGZ014, 11KGZ015, 11LGZ002, 11LGZ003, 11LGZ004, 11LGZ005, 11LGZ006, 11LGZ007, 11LGZ008, 11LGZ009, 11LGZ010, 11LGZ011, 11LGZ012, 11LGZ013, 11LGZ014, 11LGZ015, 11LGZ016, 11LGZ017, 11LGZ018, 11MGZ001, 11MGZ002, 11MGZ003, 12AGZ001, 12AGZ003, 12AGZ004, 12AGZ005, 12AGZ006, 12AGZ007, 12AGZ008, 12AGZ009, 12AGZ010, 12AGZ011, 12AGZ012, 12AGZ013, 12AGZ014, 12AGZ015, 12AGZ016, 12BGZ001, 12BGZ002, 12BGZ003, 12BGZ004, 12BGZ005, 12BGZ006, 12BGZ008, 12BGZ009, 12CGZ001, 12CGZ002, 12CGZ003, 12CGZ004, 12CGZ005, 12CGZ006, 12CGZ008, 12CGZ009, 12CGZ010, 12CGZ011, 11GGZ005, 11HGZ004, 11HGZ006.
Recalling Firm/
Manufacturer
ConMed Electrosurgery
14603 E Fremont Ave
Centennial, Colorado 80112-4251
For Additional Information Contact Jason Mingilton
303-269-8294
Manufacturer Reason
for Recall
An investigation of the ConMed Electrosurgery Altrus Energy Source revealed that the device could have been calibrated incorrectly resulting in error messages or delays in surgery.
Action ConMed Electrosurgery sent an "URGENT: MEDICAL DEVICE" letter dated May 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory for the affected product and to complete and return a Business Reply Form to the firm via fax to 303-699-9854.
Quantity in Commerce 122 units
Distribution Nationwide Distribution and the country of Canada.
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
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = CONMED CORP.
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