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U.S. Department of Health and Human Services

Class 3 Device Recall OMNIBotics Tracker Kit

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  Class 3 Device Recall OMNIBotics Tracker Kit see related information
Date Initiated by Firm October 14, 2016
Date Posted November 17, 2016
Recall Status1 Terminated 3 on February 01, 2017
Recall Number Z-0610-2017
Recall Event ID 75499
510(K)Number K090953  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product OMNIBotics Tracker Kit -Model: RM-10000

The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty
Code Information Lot number: 19-09-021
Recalling Firm/
480 Paramount Dr
Raynham MA 02767-1085
Manufacturer Reason
for Recall
Incorrect lot number on outer kit
FDA Determined
Cause 2
Error in labeling
Action The firm, OMNIlife Science, Inc., issued an "URGENT MEDICAL DEVICE ADVISORY NOTICE" dated 10/14/16 by email to its consignees/customers. U.S. and foreign agents were also sent the notification packet via overnight mail. Acknowledgement of receipt is requested. The notice described the product, problem and actions to be taken. The customers were instructed to immediately quarantine lot 19-09-021 for OMNIBotics Tracker Kit RM-1000; overlabel the outside packaging with the label provided following the provided training paperwork and rework instructions; note advisory notice only includes listed product, it does not affect other lots; and complete and return the Acknowledgement and Receipt Form and accompanying FN-102 by Fax to 508-519-3390. Accounts are to hold item RM-10000 with the lot # 19-09-021 until a corrected label is provided for the outer box. The patient labels inside the box are correct. For further information , Regulatory Affairs Specialist at 774-226-1847 or 800-448-6664 Monday through Friday, 8:00 AM to 4:30 PM, Easter Time.
Quantity in Commerce 15 units
Distribution Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.
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 = OLO and Original Applicant = PRAXIM MEDIVISION, SA