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  Class 2 Device Recall PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK see related information
Date Initiated by Firm June 30, 2016
Date Posted August 18, 2016
Recall Status1 Terminated 3 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
Recalling Firm/
MicroPort Orthopedics Inc.
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact Rachael Wise
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 2
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 and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.