Recall of Foundation Hip System Bipolar Modular

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
    hip prosthesis - Product Code KWY
  • Reason
    Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
  • Action
    Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement.


  • Model / Serial
    Lot #: 677621, 679061, 679071, 679081, 679091, 633841, 695881, 899041 and 989991.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide, including USA, Greece, Japan, and Saudi Arabia.
  • Product Description
    Foundation¿ Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
  • Manufacturer


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