Events

Recall of Device Recall Medtronic Midas Rex Legacy

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Power Surgical Solutions.

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
    30904
  • Event Risk Class
    Class 3
  • Event Number
    Z-0441-05
  • Event Initiated Date
    2005-01-03
  • Event Date Posted
    2005-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36788
  • 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, Surgical Instrument, Pneumatic Powered - Product Code GET
  • Reason
    Device is missing the sub-collet component within the dissecting tool package.
  • Action
    The firm initiated the recall by letter on 01/03/2005. Firm representative will remove recalled product and replace with new product.

Device

Device Recall Medtronic Midas Rex Legacy
  • Model / Serial
    Lot Number 7087E
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to three consignees in CA.
  • Product Description
    Medtronic Midas Rex Legacy Telescoping Dissection Tool, Model TDQ-130D, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas 76137
  • Manufacturer
    Power Surgical Solutions

Manufacturer

Power Surgical Solutions
  • Manufacturer Address
    Power Surgical Solutions, 4620 N Beach St, Fort Worth TX 76137-3219
  • Source
    USFDA