Therigraft Tcp Putty Bone Void Filler

• • Terminated Z-0169-2011 FDA Unclassified (pre-2012) ·initiated 26 Aug 2010 ·on shared 510(k) K053228

  The firm's quality control testing determined that a separation was occurring between the flowable carrier and the B-TriCalcium Phosphate within some of the product syringes.

• • Terminated Z-2375-2008 FDA Unclassified (pre-2012) ·initiated 11 Jul 2008

  The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K053228 ↗

FDA Product Code

MQV

Device Class

Class II

Regulation

21 CFR Part 888.3045

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Therilink Bone Void Filler

  Class II

  FDA 510(k) K040134 Active Cleared 9 Mar 2004

• Theriridge Block, Bone Graft Substitute

  Class II

  FDA 510(k) K023998 Active Cleared 26 Mar 2003

• THERIFIL Bone Filler

  Class II

  FDA 510(k) K031040 Active Cleared 24 Jul 2003