U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.
제품 설명
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