Events

Recall of Device Recall iTotal Posterior Stabilized (PS) 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
    78902
  • Event Risk Class
    Class 2
  • Event Number
    Z-0600-2018
  • Event Initiated Date
    2017-07-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160828
  • 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
    Implant kit mislabeled.
  • Action
    On July 10, 2017, ConforMIS notified their Sales Representatives about a possible product mislabeling. On July 11, 2017, ConforMIS secured impacted product. On July 21, 2017, ConforMIS issued a Memorandum to their Sales Representatives. ConforMIS requested that the kits be returned to ConforMIS for investigation and disposition. For further questions, please call (781) 345-9001.

Device

Device Recall iTotal Posterior Stabilized (PS) Knee Replacement System
  • Model / Serial
    Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of :CA and TX.
  • Product Description
    Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ || 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, patellofemoral, or bicompartmental prosthesis.
  • 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