Recall of Device Recall Howmedica

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics.

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
    The device is demonstrating early wear and delamination.
  • Action
    Recall letters were sent to the Howmedica branches and hospitals on January 23, 2003 via FedEx.


  • Model / Serial
    Catalog No. 66402334 Lot MAXT
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Howmedica distributed this device to 2 Howmedica branches and 3 hospitals are Parkview Episcopal Hospital, Pueblo, CO; St. Mary Corwin Hospital, Pueblo, CO; and Hement Valley Hospital, Riverside, CA.
  • Product Description
    Interax Knee Midi 1 Tibial Inserts. IX HC Tib Ins Midi 1 14mm R.
  • Manufacturer


  • Manufacturer Address
    Stryker Howmedica Osteonics, 300 Commerce Court, Mahwah NJ 07430
  • Source