Class II — Potential Health Hazard

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

Mazor X Surgical System Positioner Type II Recalled by Medtronic Navigation, Inc. Due to There is a potential for the surgical system...

Date: December 5, 2019
Company: Medtronic Navigation, Inc.
Status: Ongoing
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 Navigation, Inc. directly.

Affected Products

Mazor X Surgical System Positioner Type II, REF: ASM0214-02

Quantity: 177 Systems

Why Was This Recalled?

There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)]

Where Was This Sold?

This product was distributed to 28 states: AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KY, MA, MI, MN, MO, NY, NC, ND, OH, PA, SC, TN, TX, UT, VA, WA, WV, WI

Affected (28 states)Not affected

About Medtronic Navigation, Inc.

Medtronic Navigation, Inc. has 91 total recalls tracked by RecallDetector.

Related Recalls

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