Enseal G2 Tissus Sealers

• • Terminated Z-0758-2013 FDA Class II ·initiated 6 Nov 2012

  Potential for self activation while the device is in use, which may result in unintended thermal damage.

• 4 recalls, same reason

  • Terminated Z-1246-2012 FDA Not yet classified ·initiated 26 Jan 2012 ·via K112033, on the same 510(k)
  • Terminated Z-1247-2012 FDA Not yet classified ·initiated 26 Jan 2012 ·via K112033, on the same 510(k)
  • Terminated Z-1245-2012 FDA Not yet classified ·initiated 26 Jan 2012 ·via K112033, on the same 510(k)
  • Terminated Z-1244-2012 FDA Not yet classified ·initiated 26 Jan 2012

  Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K112033 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Ees Single Site Laparoscopic Seal Cap Assembly W/Accessories, Model SSL3P, Ees Fixed- Length Access Retractors

  Class II

  FDA 510(k) K091211 Active Cleared 4 Sep 2009

• Mammomark, Mammomark Mr and Cormark Biopsy Site Identifiers

  Class II

  FDA 510(k) K082278 Active Cleared 16 Dec 2008

• Echelon Zebra Cartridges, Models, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP

  Class II

  FDA 510(k) K080972 Active Cleared 3 Jul 2008

• Ligamax 5

  Class II

  FDA 510(k) K110699 Active Cleared 25 Mar 2011

• Ethicon Endo-Surgery Generator G11, Model GEN11

  Class II

  FDA 510(k) K101990 Cleared 13 Jun 2011