U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Reports received regarding disassembly of t-handle driver components during surgery dropping the closure top into the surgical site.
조치
Firm sent notification letters to sales agents via letter on 03/24/08. Enclosed with the notification letter, the firm provided updated product inserts for the InCompass¿ and PathFinder¿ Spinal Fixation System (Cat. #2199-0002-LB Rev. H and #1199-0002-LB Rev. H, respectively), as well as the "Disassembly and Assembly Instructions for PathFinder¿ & InCompass¿ T-Handle Drivers" (Cat #1199-0040-MKC Rev. A).
Sales Agents instructed to distribute updated inserts and instructions to all locations that handle the drivers for cleaning and to destroy all copies of old inserts.
If you have questions or have not received the recall notice from the firm, contact Kirstin Widding at 512-533-1852.