Class 2 Device Recall Turon Humeral Head Trials

• Date Initiated by Firm: November 05, 2010
• Date Posted: December 22, 2010
• Recall Status: Terminated on April 05, 2011
• Recall Number: Z-0798-2011
• Recall Event ID: 57210
• 510(K)Number: K080402
• Product Classification: orthopedic instrument - Product Code KWS
• Product: Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
• Code Information: Part numbers: 804-05-021, 804-05-022, 804-05-023, 804-05-024, 804-05-025, 804-05-026, 804-05-027, 804-05-028, 804-05-029, 804-05-030, 804-05-031, 804-05-032, 804-05-033, 804-05-034, 804-05-035, 804-05-036, 804-05-037, 804-05-038, 804-05-039, 804-05-040, 804-05-041, 804-05-042, 804-05-043, 804-05-044, 804-05-045
• 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 trial products.
• FDA Determined Cause: Device Design
• Action: Encore Medical notified consignees by letter on 11/5/2010.
• Quantity in Commerce: 425 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