Devices

Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee

  • Model / Serial
    Part Number: CP116574 Lot Number: 073840
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.
  • Product Description
    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. || This Rotating Hinged Knee is intended to replace patient anatomy.
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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