Reported Jan 28, 2026 · Ongoing

Mazor X robotic guidance system REF: TPL0059

Mazor Robotics Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mazor Robotics Ltd · North Industrial Park · Caesarea · N/A

Is this the product you have?

  • Mazor X robotic guidance system REFTPL0059
Lot codes and dates
  • Software versions
    • 5.0.1
    • 5.1.2
    • 5.1.3/
  • UDI
    • 07290109180465
    • 07290109184524
    • 07290109181158
    • 00763000635169
    • 07290109183213
    • 07290109184517
    • 00763000419134
    • 00763000431761
    • 07290109184098
    • 07290109184838
    • 07290115751376
    • 07290115751895
Amount recalled
549 systems

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.