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...
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
About Medtronic Navigation, Inc.
Medtronic Navigation, Inc. has 91 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report