Thor Anterior Plating System

• 31 recalls, same reason

  • Terminated Z-0452-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0428-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0430-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0436-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0447-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0454-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0434-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0432-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0435-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0437-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0446-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0450-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0440-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0443-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0453-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0431-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0426-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0438-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0439-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0441-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0451-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0427-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0448-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0444-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0433-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0424-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0442-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0425-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0429-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0449-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0445-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009

  Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.

510(k) Number

K073437 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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