Synthes (USA) Modular Mini Fragment Lcp System

• • Terminated Z-2389-2016 FDA Class II ·initiated 28 Jun 2016

  It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive.

• • Terminated Z-0323-2016 FDA Class II ·initiated 2 Nov 2015 ·on shared 510(k) K063049

  It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).

• • Terminated Z-0167-2016 FDA Class II ·initiated 6 Oct 2015

  Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.

• • Terminated Z-0380-2014 FDA Class II ·initiated 31 Jul 2013

  Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K063049 ↗

FDA Product Code

HRS

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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