Recall of Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Biomet, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Reason
    A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. after the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a cocrmo screw included as a component of the implant, which contains nickel.
  • Action
    The firm contacted the surgeon who received / implanted the device. The product has been implanted, so it is not subject to being returned.


  • Model / Serial
    Part Number: CP116574 Lot Number: 073840
  • Product Classification
  • Device Class
  • Implanted device?
  • 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


  • 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