Synthes Radial Head Prosthesis System

• • Terminated Z-1124-2017 FDA Class II ·initiated 29 Dec 2016

  There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.

• • Terminated Z-1238-2013 FDA Class II ·initiated 22 Feb 2013

  The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.

510(k) Number

K112030 ↗

FDA Product Code

KWI

Device Class

Class II

Regulation

21 CFR Part 888.3170

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Synthes Light Guide

  Class II

  FDA 510(k) K993314 Active Cleared 6 Dec 1999

• Synthes Locking Hand Plates

  Class II

  FDA 510(k) K092247 Active Cleared 25 Sep 2009

• Synthes Matrix Mis Rods

  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

• Synthes Lcp Proximal Tibia Plate

  Class II

  FDA 510(k) K011978 Active Cleared 9 Aug 2001

• Synthes Locking Calcaneal Plates

  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

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