Mazor X Robotic System Software Errors Risk Incorrect Spinal Surgery

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Recalling firmMazor Robotics LtdNorth Industrial Park, 5, Shakham · Caesarea, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Mazor Robotics is recalling its Mazor X robotic guidance system due to software errors that could lead to incorrect surgical instrument placement during spinal surgery. This poses a risk of potential harm to patients during procedures.

Why it’s dangerous

Software errors in versions 5.0.1, 5.1.2, and 5.1.3 can cause the robotic system to position surgical instruments incorrectly during spinal surgery. This may lead to unintended tissue damage or complications for patients.

Who’s affected

Surgical teams using the Mazor X robotic guidance system with specific software versions are affected. Patients undergoing spinal surgery with this system are at risk of incorrect instrument placement.

How to tell if you have this one

Check for software versions 5.0.1, 5.1.2, or 5.1.3 on the Mazor X system. The unique device identifiers (UDIs) listed in the recall include specific numbers like 07290109180465 and 07290109184524.

Brand
Mazor Robotics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your Mazor X system; affected versions are 5.0.1, 5.1.2, or 5.1.3.
Contact Manufacturer
Reach out to Mazor Robotics for guidance on next steps if your system is affected.

✎ GovInfoNow

Questions people ask

What software versions are affected?

Software versions 5.0.1, 5.1.2, and 5.1.3 are affected.

How can I tell if my Mazor X system is affected?

Check for software versions 5.0.1, 5.1.2, or 5.1.3. Affected units have unique device identifiers (UDIs) listed in the recall.

What should I do if my system is affected?

Contact Mazor Robotics for guidance on next steps; the recall does not specify a fix or replacement.

Take action

Contact Mazor Robotics

We’ve drafted a message you can send Mazor Robotics to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1122-2026 — Mazor Robotics Mazor Robotics

Hello,

I own a Mazor Robotics that is covered by recall Z-1122-2026 from Mazor Robotics.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1122-2026 (December 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1122-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.

Mazor Robotics Ltd recalls Mazor X robotic guidance system REF: TPL0059

Use caution until it’s fixed