Health product recall

Midas Rex Legend, Burr-Tapered

Last updated

Summary

Product
Midas Rex Legend, Burr-Tapered
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Midas Rex Legend, Burr-Tapered

0228714562
0228582219
0228582216
0228714563

F2/8TA23S

Issue

In October 2024, Medtronic became aware of a manufacturing issue involving Midas Rex Legend Fluted Spiral Tool that rendered the tools unusable. The cutting head of the F2/8TA23S tool is manufactured on a CNC grinder from a rod of material. The grinding process can leave excess material (burrs) as it grinds the cutting flutes into the stem. A deburring process downstream removes this material. It was determined that the process was not adequately performed for approximately six months in 2024. These burs can prevent the tool from being inserted into an attachment and therefore prevent the device from being used to perform a surgical procedure.

Recall Start Date: April 30, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Medtronic Powered Surgical Solutions

4620 North Beach Street, Fort Worth, Texas, United States, 76137

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77430

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