Mazor Robotics Ltd is recalling 549 Mazor X robotic guidance systems due to software errors in versions 5.0.1, 5.1.2, and 5.1.3. These errors can cause surgical instruments to be positioned incorrectly during spinal surgery, which may result in serious patient harm. Healthcare providers and surgical facilities should stop using the affected systems and contact the manufacturer or their Medtronic representative to arrange for a software update or correction.
The software defects can lead to the robotic system providing incorrect guidance, potentially causing surgical tools to be placed in unintended locations during delicate spinal procedures. While this is a voluntary firm-initiated recall, errors in instrument positioning during spinal surgery carry a significant risk of physical injury.
Recall Z-1122-2026; Quantity affected is 549 systems.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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