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U.S. Department of Health and Human Services

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

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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/
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 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.
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