Osteofil, Optefil, Regenafil, Rti Allograft Paste

• • Terminated Z-2634-2011 FDA Unclassified (pre-2012) ·initiated 9 Apr 2011

  RTI Biologics issued a recall of Osteofil DBM Paste, 5cc that was distributed on 03/04/2008 to one customer. The product was labeled as 5.0cc but should have been labeled as 0.5cc. All customers were notified of this recall on 04/09/2011.

• 12 recalls, same reason

  • Terminated Z-0487-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0492-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0497-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0490-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0500-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0499-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0494-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0481-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0493-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0498-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0491-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0496-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005

  The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.

510(k) Number

K043420 ↗

FDA Product Code

MQV

Device Class

Class II

Regulation

21 CFR Part 888.3045

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Sterling Interference Screw St

  Class II

  FDA 510(k) K050767 Active Cleared 9 Jun 2005

• Opteform, Osteofil, Rti Allograft Paste Ic, Rti Allograft Strip Ic

  Class II

  FDA 510(k) K043421 Active Cleared 16 Feb 2005

• Regenafil, Regenaform, Alriva Dbm Paste, Sltiva Dm with Cortical Cancellous Ships, Bioset, Sioset Ic, Rti Allograft Past

  Class II

  FDA 510(k) K080418 Active Cleared 30 Apr 2008

• Sterling If Screw Eyelet, Model CID3936 and Sterling Cross-Pin Eyelet, Model CID3937

  Class II

  FDA 510(k) K063584 Active Cleared 9 May 2007

• Bioset Xc

  Class II

  FDA 510(k) K060180 Active Cleared 6 Sep 2006

• Sterling Interferenc Screw Ht

  Class II

  FDA 510(k) K052405 Active Cleared 16 Nov 2005

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