Events

Recall of Device Recall Foundation

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
    Recall
  • Event ID
    29130
  • Event Risk Class
    Class 3
  • Event Number
    Z-1010-04
  • Event Initiated Date
    2004-05-10
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33182
  • 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.

Device

Device Recall Foundation
  • Model / Serial
    Catalog number 324-01-106, Lot number 991151
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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
    Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
  • Manufacturer
    Encore Medical, LP

Manufacturer

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