Sbi Lateral Rhead Implant

• 13 recalls, same reason

  • Terminated Z-2671-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2665-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2673-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2675-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2672-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2674-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2664-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2667-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2663-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2669-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2668-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2670-2018 FDA Class II ·initiated 24 Oct 2017
  • Terminated Z-2666-2018 FDA Class II ·initiated 24 Oct 2017

  Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

• • Terminated Z-0098-2014 FDA Class II ·initiated 6 Sep 2013

  The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.

510(k) Number

K062898 ↗

FDA Product Code

KWI

Device Class

Class II

Regulation

21 CFR Part 888.3170

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Mini Rail External Fixator System

  Class II

  FDA 510(k) K093550 Active Cleared 7 Jan 2010

• Sbi Forefoot Set

  Class II

  FDA 510(k) K063635 Active Cleared 29 Aug 2007

• Anatomic Ankle Arthrodesis Interlocking Nail(A3 Interlocking Nail )

  Class II

  FDA 510(k) K112982 Active Cleared 2 Apr 2012

• Sbi K-Wires

  Class II

  FDA 510(k) K051605 Active Cleared 10 Aug 2005

• Sbi Wristfit

  Class II

  FDA 510(k) K051747 Active Cleared 6 Sep 2005

• Modification to:sbi Ringfix

  Class II

  FDA 510(k) K071394 Active Cleared 29 Jun 2007

See all devices from Small Bone Innovations, Inc. →