Recall of Device Recall 3DKNEE

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 3
  • 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
    Labeling is switched for the two products recalled. 3dknee is labeled as foundation and foundation is labeled as 3dknee.
  • Action
    The firm sent recall letters to all consignees on May 10, 2004 requesting return of the product.


  • Model / Serial
    Catalog number 333-02-106; Lot numbers 991141 and 991131
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany.
  • Product Description
    3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
  • Manufacturer


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