Events

Recall of iTotal Cruciate Retaining (CR) 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
    Recall
  • Event ID
    75553
  • Event Risk Class
    Class 2
  • Event Number
    Z-0658-2017
  • Event Initiated Date
    2016-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150776
  • 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
    Mislabeled: incorrect serial number on the f4 a/p cut guide ijig.
  • Action
    ConforMIS notified the sales representative on 10/18/16 after it became aware of the device mix-up. The sales representative was requested to return any remaining components from iTotal CR kit S/N: 0381042.

Device

iTotal Cruciate Retaining (CR) Knee Replacement System
  • Model / Serial
    Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to the states of CO and NV.
  • Product Description
    ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile || Catalog Number: TCR-111-1111. || Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use || of a prosthetic device.
  • Manufacturer
    ConforMIS, Inc.

Manufacturer

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