Devices

Device Recall MARROWSTIM CONCENTRATION KIT & MARROWSTIM MINI CONCENTRATION KIT

  • Model / Serial
    REF 800-0611A, Lot Numbers 337920 and 337930 and REF 800-0613A, Lot Number 337890.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including states of Massachusetts and Minnesota and countries of Germany and Italy.
  • Product Description
    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.
  • Manufacturer
    Biomet, Inc.
  • 1 Event

Manufacturer

Biomet, Inc.
  • Manufacturer Address
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “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.
  • Source
    USFDA