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Midas rex legend, burr-tapered

Official notice

12 May 2025

Last checked

12 May 2025

Medium riskHealth Canada

An official Health Canada notice concerns Midas rex legend, burr-tapered. 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 Published 2025-05-12.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77430

Official notice

2025-05-12

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77430

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Affected products

Product 1

Affected products - Midas Rex Legend, Burr-Tapered, Lot or serial number - 0228714562 0228582219 0228582216 0228714563, Model or catalog number - F2/8TA23S

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic Powered Surgical, Midas Rex Legend Burr-tapered.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77430

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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