Stop using now Medical device recall · FDA · Published December 5, 2019

Medtronic Mazor X Surgical System Positioner Type II Recall: Risk of Falling on Patient

Medtronic recalls Mazor X Surgical System Positioner Type II (REF: ASM0214-02) due to potential detachment from the operating table, which could fall on a patient causing injury.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2330-2020Medical device Medtronic ›

Stop using this now

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)]

Take action

Contact the company

Recalling firmMedtronic Navigation, Inc.826 Coal Creek Cir · Louisville, CO 80027-9710

✎ GovInfoNow plain-language explainer

Medtronic is recalling its Mazor X Surgical System Positioner Type II model because it might detach from the operating table and fall on a patient, causing injury like bleeding or fractures. This is a serious risk during surgery. Read more at govinfonow.com/recall/66400-medtronic-mazor-x-surgical-system-positioner-type-ii-recall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66400-medtronic-mazor-x-surgical-system-positioner-type-ii-recall-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2330-2020

Cite this page

“Medtronic Mazor X Surgical System Positioner Type II Recall: Risk of Falling on Patient.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66400-medtronic-mazor-x-surgical-system-positioner-type-ii-recall-risk. Based on FDA recall #Z-2330-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2330-2020%22&limit=1).

Medtronic Navigation, Inc. recalled Mazor X Surgical System Positioner Type II units on Dec. 5, 2019, according to the FDA. The devices may detach from the operating table, potentially causing patient injury. Owners should contact Medtronic for a remedy.

How to tell if you have it

Brand: Medtronic
Product: Mazor X Surgical System Positioner Type II
REF: ASM0214-02
Lots: All Lots

The hazard

The surgical system may detach from the operational room table unexpectedly. This could result in the system falling onto the patient, causing blunt injury such as hemorrhage, hematoma, bleeding, or fractures.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has had 25 other recalls since June 7, 2017. Recent Medtronic recalls include PIN surgical pins that may not fit patient reference frames on Dec. 4, 2024, and StealthStation S8 software issues reported on Aug. 22, 2024. Other recent recalls of similar products include Philips Azurion 5 M12 System Software Recalls (Jan. 26, 2026), Mazor X Robotic System Software Errors (Dec. 10, 2025), and GE Maxxus Nuclear Medicine Systems Recall (Dec. 10, 2025).

How to tell if you have this one

Check for the Mazor X Surgical System Positioner Type II model with reference number ASM0214-0: All lots are affected. This device is used in operating rooms during surgical procedures.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately stop using the Mazor X Surgical System Positioner Type II (REF: ASM0214-02) as it could detach and fall on a patient.

Where it went and when

Where it was distributed

Distributed in 28 states, and outside the U.S.

FDA distribution: “US: ALAR,AZ,CA,CO,CT,FL,GA,IA,ID,IL,IN,KY,MA,MI,MN,MO,NC,ND,NL,NY,OH,PA,SC,TN,TX,UT,VA,WA,WI,WV, OUS: Australia, China, India, Israel, Romania, Singapore, Thailand, United Kingdom, Switzerland, Spain, Germany, Belgium,” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, New York, North Carolina, North Dakota, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 6 months after the firm started it.

Dec 5, 2019Firm started the recall
Jun 9, 2020FDA classified it Class II
Jun 17, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66400-medtronic-mazor-x-surgical-system-positioner-type-ii-recall-risk">Medtronic Mazor X Surgical System Positioner Type II Recall: Risk of Falling on Patient (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2330-2020 (December 5, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2330-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.