Reported Jun 17, 2020 · Ongoing
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Medtronic Navigation, Inc.
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: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
- Mazor X Surgical System Positioner Type II
- REFASM0214-02
- Lot codes and dates
- All Lots
- Amount recalled
- 177 Systems
Where it was sold
Why it was recalled
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)]
This product could cause temporary or reversible health problems — stop using it.
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