Synthes (USA) Trochanteric Fixation Nail (Tfn) System

• • Terminated Z-0604-2018 FDA Class II ·initiated 21 Jul 2017

  The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.

• • Terminated Z-0375-2016 FDA Class II ·initiated 2 Nov 2015

  TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.

• • Terminated Z-0219-2015 FDA Class II ·initiated 29 Oct 2014

  The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.

• • Terminated Z-0387-2014 FDA Class II ·initiated 31 Jul 2013

  The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.

• • Terminated Z-0474-2014 FDA Class II ·initiated 30 Jul 2013

  Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

• • Terminated Z-0452-2014 FDA Class II ·initiated 30 Jul 2013

  Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.

• • Terminated Z-2058-2013 FDA Class II ·initiated 2 Nov 2012

  Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.

510(k) Number

K011857 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

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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