FDA Medical Device Recalls (openFDA)
ConMed Electrosurgery: 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.
- Recall number
- Z-1678-2012
- Recalling firm
- ConMed Electrosurgery
- 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.
- Status
- Terminated
- Initiated
- 2012-05-07
- Posted
- 2012-05-29
- Terminated
- 2012-06-19
- 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.
- Root cause
- Equipment maintenance
- 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
- 122 units
- Distribution
- Nationwide Distribution and the country of Canada.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K101534"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3004491689
- Firm city
- Centennial
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28