Events

Recall of ConforMIS iUni

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
    51903
  • Event Risk Class
    Class 2
  • Event Number
    Z-1623-2009
  • Event Initiated Date
    2009-04-23
  • Event Date Posted
    2009-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81654
  • 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, non-constrained, cemented, metal/polymer - Product Code HSX
  • Reason
    Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
  • Action
    ConforMIS contacted accounts and presented the surgeon with the customer communication letter dated April 23, 2009, customized for the surgeon by serial number and patient identification. Product not yet implanted will be recovered. A patient evaluation and monitoring protocol will be recommended for potentially affected product already implanted. Contact ConforMIS for further questions at 1-781-345-9164.

Device

ConforMIS iUni
  • Model / Serial
    Serial Numbers: 2571, 2706, 1755, 2665, 1757 and 2749.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including states of CA, LA, MI and TX and Germany.
  • Product Description
    ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M57220600020. || For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component.
  • Manufacturer
    Conformis Inc

Manufacturer

Conformis Inc
  • Manufacturer Address
    Conformis Inc, 2 Forth Ave, Burlington MA 01803
  • Manufacturer Parent Company (2017)
    Conformis Inc
  • Source
    USFDA