Events

Recall of Device Recall Conformis

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
    62576
  • Event Risk Class
    Class 2
  • Event Number
    Z-2222-2012
  • Event Initiated Date
    2012-07-17
  • Event Date Posted
    2012-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111079
  • 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
    Addendum labeling itotal cr surgical technique with detailed instructions of total cr poly insertion technique.
  • Action
    ConforMIS sent an Urgent Field Safety Notice letter dated July 5, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. An Addendum is included that provided updates to the Surgical Technique Guide. The updated technique guide will be delivered to all iTotal surgeons along with an on-site vist from ConforMIS sales representative. Customers were instructed to place the Surgical Technique Guide Addendum alongside the surgical plan, it puts the information in a highly visible location for the surgeon to review prior to the surgical procedure. Customers were asked to sign the communication verification form attached. For any questions regarding this notice, please contact your local ConforMIS representative or MDSS GmbH, Tel.: +49-511-62628630, info@mdss.com.

Device

Device Recall Conformis
  • Model / Serial
    All serial numbers
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Germany
  • Product Description
    Conformis iTotal CR-Cruciate Retaining Knee Replacement System || Model Numbers: || M57250600010 iTotal CR, Left Knee || M57250600020 iTotal CR, Right Knee || Product Usage : Usage: || The iTotal CR Knee Replacement System (KRS) is 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 that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.
  • Manufacturer
    Conformis Inc

Manufacturer

Conformis Inc
  • Manufacturer Address
    Conformis Inc, 1 North Ave, Suite B, Burlington MA 01803-3305
  • Manufacturer Parent Company (2017)
    Conformis Inc
  • Source
    USFDA