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Health Canada Medical devices

Midas Rex Legend, Burr-Tapered

Issued May 12, 2025
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
Hazard description
Performance
Product
Product name
Midas Rex Legend, Burr-Tapered
Reference
ID
RA-77430