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

• 3 recalls, same reason

  • Terminated Z-1689-2019 FDA Class II ·initiated 26 Apr 2019
  • Terminated Z-1688-2019 FDA Class II ·initiated 26 Apr 2019
  • Terminated Z-1690-2019 FDA Class II ·initiated 26 Apr 2019

  The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.

• • Terminated Z-1441-2017 FDA Class II ·initiated 23 Jan 2017

  Incorrect instructions for use (IFU) included.

• • Terminated Z-0939-2014 FDA Class II ·initiated 6 Dec 2013

  RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.

• 8 recalls, same reason

  • Terminated Z-0485-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0488-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0483-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0489-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0501-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0495-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0484-06 FDA Unclassified (pre-2012) ·initiated 14 Oct 2005
  • Terminated Z-0482-06 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

K043421 ↗

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

• 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

• Osteofil, Optefil, Regenafil, Rti Allograft Paste

  Class II

  FDA 510(k) K043420 Active Cleared 10 Feb 2005

• 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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