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U.S. Department of Health and Human Services

Class 3 Device Recall Lineage Shell

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  Class 3 Device Recall Lineage Shell see related information
Date Initiated by Firm June 21, 2016
Date Posted December 01, 2016
Recall Status1 Terminated 3 on July 01, 2017
Recall Number Z-0686-2017
Recall Event ID 75063
510(K)Number K100866  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464
For use with the conserve metal head
Code Information REF 36693646 Serial Numbers: 09230967, 09229086, 10230508  REF 36693848 Serial Numbers: 08228745, 10230509, 11235075  REF 36694050 Serial Numbers: 09229091, 09230501  REF 36694252 Serial Numbers: 09229131, 10230510  REF 36694454 Serial Numbers: LLALMB161A, 09230503  REF 36694656 Serial Numbers: 09230505, 11230847  REF 36694858 Serial Numbers: 09229167, 10230511  REF 36695060 Serial Numbers: 09229169, 09230506  REF 36695262 Serial Numbers: 09230507, 09229170  REF 36695464 Serial Numbers: 08228747, 10230512 
Recalling Firm/
Manufacturer		 MicroPort Orthopedics Inc.
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact Rachael Wise
901-867-4771
Manufacturer Reason
for Recall		 Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
FDA Determined
Cause 2		 Device Design
Action MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers notifying them of the change in the instructions for use on July 7th, 2016 by email. The firm also notified US hospitals where the implantation surgeries occurred within the last twelve (12) months by letter on July 13th, 2016 delivered by FedEx Priority. Customers were asked to complete and return the enclosed form even if they do not have any affected product to return by fax to 1-901-451-6032 or PostMarket@ortho.microport.com. For questions regarding this recall call 901-867-4771.
Quantity in Commerce 22 units
Distribution Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
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 = LZO and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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