Confidence High Viscosity Bone Cement

• • Terminated Z-1300-2018 FDA Class II ·initiated 15 Dec 2017

  Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.

• 3 recalls, same reason

  • Terminated Z-2132-2013 FDA Class II ·initiated 17 Apr 2013
  • Terminated Z-2133-2013 FDA Class II ·initiated 17 Apr 2013
  • Terminated Z-2134-2013 FDA Class II ·initiated 17 Apr 2013

  During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.

• 4 recalls, same reason

  • Terminated Z-0960-2013 FDA Class II ·initiated 15 Jan 2013
  • Terminated Z-0961-2013 FDA Class II ·initiated 15 Jan 2013
  • Terminated Z-0963-2013 FDA Class II ·initiated 15 Jan 2013
  • Terminated Z-0962-2013 FDA Class II ·initiated 15 Jan 2013

  Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck

510(k) Number

K060300 ↗

FDA Product Code

NDN

Device Class

Class II

Regulation

21 CFR Part 888.3027

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Fixion Intramedullary Nailing System (Fixion Im Nail)

  Class II

  FDA 510(k) K003212 Active Cleared 28 Dec 2000

• Sky Bone Expander System (Sky System)

  Class II

  FDA 510(k) K040612 Active Cleared 17 Jun 2004

• Fixion Interlocking Nail (Fixion Il Nail)

  Class II

  FDA 510(k) K002783 Active Cleared 5 Dec 2000

• Fixion Interlocking Proximal Femoral Nailing System

  Class II

  FDA 510(k) K010988 Active Cleared 19 Jun 2001

• Fixion Unipolar Modular Hemi-Hip System (Fixion Uh)

  Class II

  FDA 510(k) K014072 Active Cleared 8 Mar 2002

• Modification to Fixion Intramedullary Nailing System (Fixion Im)

  Class II

  FDA 510(k) K032588 Active Cleared 12 Sep 2003

See all devices from Disc-O-Tech Medical Technologies, Ltd. →