Class 2 Device Recall Turon Pegged Glenoid Drill Guide

• Date Initiated by Firm: November 05, 2010
• Date Posted: December 22, 2010
• Recall Status: Terminated on April 05, 2011
• Recall Number: Z-0801-2011
• Recall Event ID: 57210
• 510(K)Number: K080402
• Product Classification: orthopedic instrument - Product Code KWS
• Product: Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
• Code Information: Part number 804-25-024, and 804-25-025
• Recalling Firm/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758
• For Additional Information Contact: 512-832-9500
• Manufacturer Reason for Recall: Complaints of fracturing were reported for affected trial products.
• FDA Determined Cause: Device Design
• Action: Encore Medical notified consignees by letter on 11/5/2010.
• Quantity in Commerce: 34 units
• Distribution: TX, FL, SC, GA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWS