Recall of Device Recall Conformis iTotal CR G2 Knee Replacement System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConforMIS, 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 Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • 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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting.
  • Action
    Conformis notified the consignee by telephone on 11/19/14, about the problem. A sales representative visited the site and retrieved the device.


  • Model / Serial
    Serial Number: 0340552
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Distributed to IN.
  • Product Description
    Conformis iTotal CR G2 Knee Replacement System || Catalog/Model #: M57250600010 || Intended for use as a total knee replacement in patients with knee joint pain and disability.
  • Manufacturer


  • Manufacturer Address
    ConforMIS, Inc., 28 Crosby Dr, Bedford MA 01730-1402
  • Manufacturer Parent Company (2017)
  • Source