Cobalt Bone Cement

  • Model / Serial
    Model numbers: 402282 and 402282J - Cobalt HV Bone Cement 402438 - Cobalt MV Bone Cement 402283J - Cobalt HV Bone Cement With Gentamicin  402438 Lot: 507830  402282J Lot: 668140  402282 Lot: 508220  402283J Lot: 189780
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX. Japan Mexico
  • Product Description
    Cobalt HV Bone Cement || Cobalt MV Bone Cement || Cobalt HV Bone Cement With Gentamicin
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Manufacturer Parent Company (2017)
  • 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