Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tool Legend 16cm 2.4 mm wire pass for Midas Rex Recalled by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution Due to The wire pass hole is not present on...

Date: October 21, 2015
Company: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Sofamor Danek Usa, Inc - Dallas Distribution directly.

Affected Products

Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.

Quantity: 9 pieces

Why Was This Recalled?

The wire pass hole is not present on the tools.

Where Was This Sold?

Distributed in the states of California, New York, and Texas and the country of Belgium.

About Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report