Events

Recall of Device Recall screw driver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Sofamor Danek Instrument Manufacturing.

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
    34196
  • Event Risk Class
    Class 3
  • Event Number
    Z-0330-06
  • Event Initiated Date
    2005-11-28
  • Event Date Posted
    2005-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43253
  • 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
    Screwdriver - Product Code HXX
  • Reason
    Screwdriver handle breakage.
  • Action
    The recalling firm sent out a letter dated 12/01/2005 explaining the problem and requesting return of the product.

Device

Device Recall screw driver

Manufacturer

Medtronic Sofamor Danek Instrument Manufacturing
  • Manufacturer Address
    Medtronic Sofamor Danek Instrument Manufacturing, 2975 Brother Blvd, Bartlett TN 38133-3957
  • Source
    USFDA