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.
데이터 추가 비고
Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
원인
A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.
조치
Consignees were notified by "URGENT MEDICAL DEVICE REMOVAL NOTICE " dated March 5, 2009 and instructed to locate and return the recalled products. Direct questions about this recall to Biomet Orthopedics at 1-800-348-9500 or 574-372-3983, Monday through Friday, 8AM to 5PM.
Worldwide Distribution -- USA including states of Massachusetts and Minnesota and countries of Germany and Italy.
제품 설명
Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile, Biomet Biologics, Warsaw, IN; REF 800-0611A and 800-0613A. || The device is used for the rapid preparation of platelet-poor-plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.
“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.