Conmed Altrus Thermal Tissue Fusion System

• • Terminated Z-1839-2014 FDA Class II ·initiated 20 Feb 2014

  ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.

• 2 recalls, same reason

  • Terminated Z-0332-2014 FDA Class II ·initiated 23 Oct 2013
  • Terminated Z-0331-2014 FDA Class II ·initiated 23 Oct 2013

  The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection.

• 4 recalls, same reason

  • Terminated Z-1679-2012 FDA Not yet classified ·initiated 7 May 2012
  • Terminated Z-1682-2012 FDA Not yet classified ·initiated 7 May 2012
  • Terminated Z-1681-2012 FDA Not yet classified ·initiated 7 May 2012
  • Terminated Z-1680-2012 FDA Not yet classified ·initiated 7 May 2012

  The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.

• • Terminated Z-1678-2012 FDA Not yet classified ·initiated 7 May 2012

  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.

510(k) Number

K101534 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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See all devices from Conmedcorp →