Events

Recall of Device Recall Foundation Total 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
    Recall
  • Event ID
    33991
  • Event Risk Class
    Class 2
  • Event Number
    Z-0331-06
  • Event Initiated Date
    2005-11-03
  • Event Date Posted
    2005-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42861
  • 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
    The product is mislabeled in that size 6 right foundation may contain size 8 right 3d knee non-porous baseplates and vice versa. device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
  • Action
    Firm initiated recall on 11/03/05 via letter to all consignees.

Device

Device Recall Foundation Total Knee System.
  • Model / Serial
    Lot #426142 and #426132.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.
  • Product Description
    Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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