Conmed Selectone Minimal Access Surgery Instruments

• • Terminated Z-0103-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006

  The company was made aware of instances where the grasper jaws broke during laparoscopic procedures. When the grasper jaws had broken they had done so at the junction of the jaw and the tube. In no instances was it reported to the company that small pieces had broken off of the grasper jaws.

• 21 recalls, same reason

  • Terminated Z-0108-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0096-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006 ·on shared 510(k) K943327
  • Terminated Z-0114-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0098-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0110-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0100-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0104-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0099-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0095-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0093-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0094-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0113-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0107-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0101-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0111-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0105-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0097-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0109-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0102-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0106-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0112-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006

  The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K943327 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• ECG Electrode (Various)

  Class II

  FDA 510(k) K991105 Active Cleared 26 Nov 1999

• Thermogard & Thermogard Plus Abc

  Class II

  FDA 510(k) K972628 Active Cleared 27 Aug 1997

• Conmed Universal Plus

  Class II

  FDA 510(k) K934828 Active Cleared 7 Mar 1994

• Electrosurgical Dispersive Electrode

  Class II

  FDA 510(k) K983782 Active Cleared 25 Jan 1999

• Bend-A-Beam Hand Control Malleable ABC Handpiece

  Class II

  FDA 510(k) K961505 Active Cleared 18 Jul 1996

• Exactrace Adult Foam Monitoring ECG Electrode Conmed Model 1510 and Instatrace Adult Diaphoretic Foam ECG Electrode Conm

  Class II

  FDA 510(k) K963787 Active Cleared 11 Mar 1997

See all devices from Conmedcorp →