Events

Recall of Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK.

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
    39409
  • Event Risk Class
    Class 2
  • Event Number
    Z-0114-2008
  • Event Initiated Date
    2007-09-04
  • Event Date Posted
    2007-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55431
  • 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
    electrosurgical pencil - Product Code GEI
  • Reason
    Packaging weakness may compromise sterility and instructions for use are inadequate.
  • Action
    Consignees were notified via letter dated September 4, 2007 to cease using the product and to contact the firm for instructions on how to return the product.

Device

Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil
  • Model / Serial
    All lots.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Hong Kong, India, Mexico, Netherlands, Qatar, Saudi Arabia and South Korea.
  • Product Description
    Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.
  • Manufacturer
    Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

Manufacturer

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
  • Manufacturer Address
    Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK, 2500 Silveus Crossing, Warsaw IN 46582-8598
  • Source
    USFDA