Recall of Passport A.R. Knee Instrumentation Distal Guide Stand

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

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
    knee prosthesis instrument - Product Code LXH
  • Reason
    There is the potential for the posts on the distal resection guide stand to disassociate from the main body part.
  • Action
    Stryker Urgent Product Recall letters dated April 8, 2010, were sent by Federal Express to Stryker Branches/agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. All hospitals and surgeons that used the product in the last year were notified.


  • Model / Serial
    Catalog number 7650-5005. All lots.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide distribution.
  • Product Description
    Howmedica Osteonics Corp, || Stryker Orthopaedics Passport A.R. Knee Instrumentation Distal Guide Stand; Catalog number 7650-5005.
  • Manufacturer


  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
  • Source