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
5.0.15.1.25.1.3/
- UDI
072901091804650729010918452407290109181158007630006351690729010918321307290109184517007630004191340076300043176107290109184098072901091848380729011575137607290115751895
- Software versions
- 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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