Events

Recall of Device Recall Guardian Distal Femur Axial Pin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wright Medical Technology Inc.

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
    29664
  • Event Risk Class
    Class 2
  • Event Number
    Z-1405-04
  • Event Initiated Date
    2004-07-14
  • Event Date Posted
    2004-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34305
  • 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, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
  • Reason
    Potential for self -locking axial pin to dislodge and 'back out'.
  • Action
    The firm sent out product correction notifications to implanting surgeons by letter dated 07/14/2004 to notify the surgeons of the dislodgement issue.

Device

Device Recall Guardian Distal Femur Axial Pin
  • Model / Serial
    Part No. 25002111, Serial No. 02217952 Part No. 25002112, Serial No. 01214391 Part No. 25002112, Serial No. 01215073 Part No. 25002113, Serial No. 01214533 Part No. 25002114, Serial No. 01215034 Part No. 25002114, Serial No. 01215074
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Ontario, and Taiwan, ROC
  • Product Description
    Guardian¿ Distal Femur Axial Pin
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Manufacturer Address
    Wright Medical Technology Inc, 5677 Airline Road, P.O. Box 100, Arlington TN 38002-0100
  • Source
    USFDA