Recall of Foundation Knee System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encore Medical, LP.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Product container was labeled incorrectly indicating left femur instead of right.
  • Action
    The firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors.


  • Model / Serial
    Lot numbers 811761, 815241, 815251, 817891, 834781, 835291, 838201, 850611
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    PA, TX, MA, FL, NV, AZ, and France and Saudi Arabia
  • Product Description
    Foundation Knee System, non-porous Femur Size 8, Right
  • Manufacturer


  • Manufacturer Address
    Encore Medical, LP, 9800 Metric Blvd, Austin TX 78758
  • Source