Synthes Large Combination Clamp and Dynamization Clip - Mr Safe

• • Terminated Z-2451-2015 FDA Class II ·initiated 29 Jul 2015 ·via K030390, on the same 510(k)

  Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR Conditional. One serious injury reported.

• • Terminated Z-1833-2014 FDA Class II ·initiated 10 Apr 2014 ·via K030390, on the same 510(k)

  Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K030390 ↗

FDA Product Code

LXT

Device Class

Class II

Regulation

21 CFR Part 888.3030

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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