Recall MonitorHealth Products
Midas Rex Legend, Burr-Tapered
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Orthopaedics
Product: Midas Rex Legend, Burr-Tapered
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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