medical Class II Updated 2020-06-17

Medtronic Navigation, Inc. recalls Mazor X Surgical System Positioner Type II, REF: ASM0214-02

Recalled Product

Mazor X Surgical System Positioner Type II, REF: ASM0214-02


Hazard / Issue

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)]

Issued by

FDA

Affected States: AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MI, MN, MO, NC, ND, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV
Lot/Code Info: All Lots
View official government recall

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