Events

Recall of Medtronic Midas Rex Dissecting Tool Legend

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution.

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
    73869
  • Event Risk Class
    Class 2
  • Event Number
    Z-1602-2016
  • Event Initiated Date
    2016-04-08
  • Event Date Posted
    2016-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145218
  • 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
    Motor, drill, pneumatic - Product Code HBB
  • Reason
    Incorrect color coding and attachment reference were included on the labeling of 10ba40d dissecting tools with lot number h5237248.
  • Action
    A notification letter was provided to each consignee, translated as necessary, on April 8, 2016.

Device

Medtronic Midas Rex Dissecting Tool Legend
  • Model / Serial
    Product Catalog Number: 10BA40D, Lot Number: H5237248
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
  • Product Description
    Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. || Intended for use in neurosurgery.
  • Manufacturer
    Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Manufacturer

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
  • Manufacturer Address
    Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, 4620 N Beach St, Haltom City TX 76137-3219
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA