Conmed Stealth Non-Stick Accessory Electrode, Model 138XXX

• 13 recalls, same reason

  • Terminated Z-0730-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0721-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0737-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0733-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0735-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0729-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0731-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0720-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0734-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0736-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0722-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0723-2013 FDA Class II ·initiated 27 Dec 2012
  • Terminated Z-0732-2013 FDA Class II ·initiated 27 Dec 2012

  ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.

• • Terminated Z-0452-2008 FDA Unclassified (pre-2012) ·initiated 2 Nov 2007

  Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal

510(k) Number

K991855 ↗

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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