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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Made Implant System with Minimum Invasive Grower (MIG) component

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  Class 2 Device Recall Custom Made Implant System with Minimum Invasive Grower (MIG) component see related information
Date Initiated by Firm December 21, 2017
Create Date July 28, 2018
Recall Status1 Terminated 3 on October 05, 2018
Recall Number Z-2567-2018
Recall Event ID 79485
Product Classification Device, fixation, proximal femoral, implant - Product Code JDO
Product Custom Made Implant System with Minimum Invasive Grower (MIG) component
Code Information Manufactured between March 2007 and October 2014  Prosthesis Identification Number (PIN) Date of Dispatch 16082 11Apr 2011 18313 19 Dec 2013 18666 20 Jun 2014 18713 15 Sep 2014 18800 29 Aug 2014 
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact
201-831-5000
Manufacturer Reason
for Recall		 From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.
FDA Determined
Cause 2		 Labeling design
Action On December 21, 2017 a FIELD SAFETY NOTICE was issued to customers notifying of the corrective action. An attachment was supplied with the letter titled "Minimally Invasive Grower - Instructions For Adjustment that is effective on and after October 14, 2014. Questions or concerns can be directed to your local sales representative.
Quantity in Commerce 5
Distribution NY, FL, KS
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.
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