Events

Recall of Device Recall Midas Rex Legend dissecting tool

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Powered 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
    48472
  • Event Risk Class
    Class 2
  • Event Number
    Z-2156-2008
  • Event Initiated Date
    2008-05-30
  • Event Date Posted
    2008-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71487
  • 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
    Pneumatic drill motor - Product Code HBB
  • Reason
    Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. this may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.
  • Action
    Firm notified consignees by Urgent: Medical Device Recall letter sent May 30, 2008. The letter requires consignees to immediately compare their inventory of products against the list provided and quarantine any unused dissecting tools. The letter also states that Medtronic would provide replacement product to match the quantity and type returned by the consignees' institution.

Device

Device Recall Midas Rex Legend dissecting tool
  • Model / Serial
    Lot numbers: 0000710253, 0000710254, 0000710256, 0000710257, 0000710258, 0000710266, 0000710267, 0000710271, 0000710272, 0000710274, 0000710275, 0000710276, 0000710277, 0000710278, 0000710279, 0000710280, 0000710281, and 0000710288
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 || Medtronic Powered Surgical Solutions, Forth Worth, TX || Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.
  • Manufacturer
    Medtronic Powered Surgical Solutions

Manufacturer

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