Class 2 Device Recall Trial Shell component of the accessory kit to the Shoulder Prosthesis Stem

• Date Initiated by Firm: December 08, 2015
• Date Posted: January 09, 2016
• Recall Status: Terminated on March 01, 2016
• Recall Number: Z-0626-2016
• Recall Event ID: 72809
• 510(K)Number: K141990
• Product Classification: shoulder prosthesis, reverse configuration - Product Code PHX
• Product: AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
• Code Information: 178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, 183345L06
• Recalling Firm/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758-5445
• For Additional Information Contact: Teffany Hutto; 512-834-6255
• Manufacturer Reason for Recall: The trial shell mating feature on the broach is undersized.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm notified customers of the recall via letter on 12/8/15.
• Quantity in Commerce: 23 units
• Distribution: Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX
• 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 = PHX