Synthes Vectra System

• • Terminated Z-2674-2014 FDA Class II ·initiated 2 Sep 2014

  DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems. The Vectra Systems are intended for anterior screw fixation to the cervical spine (C2-C7). It was discovered in certain lots, that the clips are potentially missing from the TI Vectra Plates resulting in the i

• 2 recalls, same reason

  • Terminated Z-0781-2013 FDA Class II ·initiated 6 Aug 2012
  • Terminated Z-0782-2013 FDA Class II ·initiated 6 Aug 2012

  Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.

510(k) Number

K050451 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Synthes Zero-P

  Class II

  FDA 510(k) K112459 Active Cleared 12 Dec 2011

• Synthes Antegra System

  Class II

  FDA 510(k) K063158 Active Cleared 14 Nov 2006

• Synex Ii

  Class II

  FDA 510(k) K061891 Active Cleared 18 Aug 2006

• Synfix -Lr

  Class II

  FDA 510(k) K062083 Active Cleared 3 Apr 2007

• Synthes Oc Fusion and Synapse Systems

  Class II

  FDA 510(k) K072434 Active Cleared 10 Jan 2008

• Synthes Zero-P Variable Angle (VA)

  Class II

  FDA 510(k) K112068 Active Cleared 7 Nov 2011

See all devices from Synthes Spine Co.Lp →