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
    72108
  • Event Risk Class
    Class 2
  • Event Number
    Z-0144-2016
  • Event Initiated Date
    2015-08-31
  • Event Date Posted
    2015-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140003
  • 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
    May contain small amounts of ethylene glycol residue.
  • Action
    ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below: Phase 1-Surgeons with product for which the surgery has not yet been completed Phase 2-Surgeons for whom product was confirmed to have been consumed/implanted. An updated Surgeon letter dated September 8, 2015 issued includes additional information for devices that have been used in surgery. Contact your local ConforMIS representative or Amita Shah, at 17813459164.

Device

Device Recall ConForMIS
  • Model / Serial
    Serial Numbers (US):  0354697, 0353789, 0354533
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed Nationwide and in Germany, Switzerland, and UK.
  • Product Description
    ConFormis iTotal CR Knee Replacement System- || ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT || ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT || Catalog Number: TCR1111111
  • 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