Events

Recall of Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.

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

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
    29675
  • Event Risk Class
    Class 2
  • Event Number
    Z-0020-05
  • Event Initiated Date
    2004-07-14
  • Event Date Posted
    2004-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34316
  • 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
    Neurological Stereotaxic Instrument - Product Code HAW
  • Reason
    The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.
  • Action
    Sales force was notified these pre-launch devices are not to be used for surgical use via e-mail and telephone calls on 7/14/04.

Device

Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.
  • Model / Serial
    Serial numbers PG04-0001 through PG04-0017.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States.
  • Product Description
    Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.
  • Manufacturer
    Stryker Instruments, Instruments Div.

Manufacturer

Stryker Instruments, Instruments Div.
  • Manufacturer Address
    Stryker Instruments, Instruments Div., 4100 E. Milham, Kalamazoo MI 49001
  • Source
    USFDA