Events

Recall of Device Recall Altrus Energy Source

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConMed Electrosurgery.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61814
  • Event Risk Class
    Class 2
  • Event Number
    Z-1678-2012
  • Event Initiated Date
    2012-05-07
  • Event Date Posted
    2012-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109155
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    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.

Device

Device Recall Altrus Energy Source
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and the country of Canada.
  • Product Description
    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.
  • Manufacturer
    ConMed Electrosurgery

Manufacturer

ConMed Electrosurgery
  • Manufacturer Address
    ConMed Electrosurgery, 14603 E Fremont Ave, Centennial CO 80112-4251
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA