Reprocessed Trocars

• • Terminated Z-0498-2019 FDA Class II ·initiated 19 Jun 2018

  Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities initially performed by distributor.

• • Terminated Z-0765-2017 FDA Class II ·initiated 11 Nov 2016

  An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.

510(k) Number

K062497 ↗

FDA Product Code

NLM

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Reprocessed Cs Bi-Diectional Diagnostic Electrophysiology Catheter Open recall

  Class II

  FDA 510(k) K100254 Active Cleared 28 May 2010

• Reprocessed External Fixation Device

  Class II

  FDA 510(k) K061759 Active Cleared 5 Sep 2006

• Reprocessed Diagnostic Ultrasound Catheter

  Class II

  FDA 510(k) K063076 Active Cleared 29 Mar 2007

• Reprocessed Electrosurgical Instrument

  Class II

  FDA 510(k) K110189 Active Cleared 18 Jul 2011

• Reprocessed Trocars

  Class II

  FDA 510(k) K070059 Active Cleared 2 Oct 2007

• Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9, Twblue, Gablue

  Unclassified

  FDA 510(k) K100537 Active Cleared 12 May 2010

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