Events

Recall of Device Recall KLite Knee 2 Stays with Visco, Model No. 122015.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Breg 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
    67821
  • Event Risk Class
    Class 2
  • Event Number
    Z-1447-2014
  • Event Initiated Date
    2014-03-14
  • Event Date Posted
    2014-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126441
  • 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
    Orthosis, limb brace - Product Code IQI
  • Reason
    Breg is recalling the economy elastic knee sleeve open and k-lite knee 2 stays with visco because they contain latex but were not labeled with the required caution label.
  • Action
    Breg representatives informed customers of the recall by telephone on March 14, 2014 and then a customer notification letter was sent to customers via email onMarch 17, 2014. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the return response form. Customers with questions are instructed to contact Breg Customer Care at (800) 321-0607.

Device

Device Recall KLite Knee 2 Stays with Visco, Model No. 122015.
  • Model / Serial
    Lot No. 705593
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.
  • Product Description
    K-Lite Knee 2 Stays with Visco, Model No. 122015. || Product Usage: || The product is intended to provide flexible knee support.
  • Manufacturer
    Breg Inc

Manufacturer

Breg Inc