Events

Recall of Device Recall Medtronic Midas REx Legend Lubricant Diffuser Cartridge

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
    30385
  • Event Risk Class
    Class 2
  • Event Number
    Z-0213-05
  • Event Initiated Date
    2004-11-03
  • Event Date Posted
    2004-11-20
  • 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=35778
  • 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
    Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).
  • Action
    The firm initiated the recall by letter on November 3, 2004 asking consignees to return unused units.

Device

Device Recall Medtronic Midas REx Legend Lubricant Diffuser Cartridge
  • Model / Serial
    A5972-V01; A5982-V01; A5991-V01; A5992-V01; A6308-V01through A6327-V01; A6666-V01 through A6684-V01; A6686-V01 through A6691-V01; A6919-V01 through A6934-V01; A7184-V01 through A7188-V01; A7194-V01through A7198-V01; A7495-V01 through A7501-V01; A7520-V01; A7521-V01; and A7525-V01
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was shipped nationwide and to the following foreign countries: Australia, Canada, Hong Kong, Japan, Netherlands, Columbia, Chile, and Venezuela.
  • Product Description
    Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas
  • Manufacturer
    Power Surgical Solutions

Manufacturer

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