Trabecular Metal Acetabular Augments

• 4 recalls, same reason

  • Terminated Z-2214-2010 FDA Unclassified (pre-2012) ·initiated 6 Apr 2010
  • Terminated Z-2217-2010 FDA Unclassified (pre-2012) ·initiated 6 Apr 2010
  • Terminated Z-2216-2010 FDA Unclassified (pre-2012) ·initiated 6 Apr 2010
  • Terminated Z-2215-2010 FDA Unclassified (pre-2012) ·initiated 6 Apr 2010

  The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.

510(k) Number

K061067 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Trabecular Metal Acetabular Revision Shells

  Class II

  FDA 510(k) K050937 Active Cleared 11 May 2005

• Modification to:trabecular Metal Femoral Cone Augments, Models 03-125-Zzzz

  Class II

  FDA 510(k) K051756 Active Cleared 27 Jul 2005

• Trabecular Metal Bone Stabilization Implant, Model 99-11197-XX-10

  Class II

  FDA 510(k) K050101 Active Cleared 15 Apr 2005

• The Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution, Model 4316-Xx-Xx

  Class II

  FDA 510(k) K043061 Active Cleared 23 Nov 2004

• The Zimmer Tmt Trabecular Metal Vertebral Body Replacement System

  Class II

  FDA 510(k) K052950 Active Cleared 16 Nov 2005

• Vista P Vertebral Body Replacement System

  Class II

  FDA 510(k) K061155 Active Cleared 22 Sep 2006

See all devices from Zimmer Trabecular →