Class 2 Device Recall PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK

• Date Initiated by Firm: June 30, 2016
• Date Posted: August 18, 2016
• Recall Status: Terminated on January 21, 2017
• Recall Number: Z-2588-2016
• Recall Event ID: 74752
• 510(K)Number: K003016
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, uncemented - Product Code LWJ
• Product: PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
• Code Information: Lot number 1645222
• FEI Number: 3010536692
• Recalling Firm/ Manufacturer: MicroPort Orthopedics Inc.; 5677 Airline Rd; Arlington TN 38002-9501
• For Additional Information Contact: Rachael Wise; 901-290-5290
• Manufacturer Reason for Recall: Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).
• FDA Determined Cause: Error in labeling
• Action: The firm initiated their recall by email on 06/30/2016.
• Quantity in Commerce: 14 units
• Distribution: Belgium, Italy, Spain, and Poland
• 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 = LWJ