Events

Recall of The GMK knee system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medacta Usa 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
    78401
  • Event Risk Class
    Class 2
  • Event Number
    Z-0266-2018
  • Event Initiated Date
    2017-10-24
  • Event Date Posted
    2017-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159432
  • 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
    Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. for this reason, we stress the importance of using the 3.5 nm torque limiting driver if the screw is used, as directed in our surgical techniques.
  • Action
    All surgeon customers shall be notified via email by October 24, 2017 of the reminder to follow the surgical technique. To ensure that surgeons receive the notification, we will send the letter via email so that we can track and ensure the message was received. If the email is returned, we would then send a personalized letter directly to the surgeon. A copy of this notification is included with the submission of this report.

Device

The GMK knee system
  • Model / Serial
    all serial numbers
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    nationwide
  • Product Description
    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
  • Manufacturer
    Medacta Usa Inc

Manufacturer

Medacta Usa Inc
  • Manufacturer Address
    Medacta Usa Inc, 3973 Delp St, Memphis TN 38118-6110
  • Manufacturer Parent Company (2017)
    Medacta Holding Sa
  • Source
    USFDA