Device Recall Zimmer Segmental Systems

  • Model / Serial
    Part numbers 00-5850-013-95
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
  • Product Description
    Zimmer Segmental Systems; Polyethylene Inserts, Size C. || Knee replacement.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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

One device with a similar name

Learn more about the data here

  • Model / Serial
    Part numbers 00-5850-012-95
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
  • Product Description
    Zimmer Segmental Systems; Polyethylene Inserts, Size B. || Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
  • Manufacturer