Synthes Vectra-One 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

K071667 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Uss Iliosacral, Uss Polyaxial

  Class II

  FDA 510(k) K082572 Active Cleared 24 Nov 2008

• Oracle Spacer, Opal Spacer

  Class II

  FDA 510(k) K072791 Active Cleared 26 Dec 2007

• Synthes Mirs

  Class II

  FDA 510(k) K113044 Active Cleared 21 Dec 2011

• Synthes Spine Posterior Universal System

  Class II

  FDA 510(k) K984612 Active Cleared 19 Jan 1999

• Synthes Cervifix System

  Class II

  FDA 510(k) K001864 Active Cleared 20 Jul 2000

• Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System

  Class II

  FDA 510(k) K980928 Active Cleared 11 May 1998

See all devices from Synthes Spine →