FDA-Device2020-06-17Class II
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Medtronic Navigation, Inc.
Hazard
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)]
Sold states
US: ALAR,AZ,CA,CO,CT,FL,GA,IA,ID,IL,IN,KY,MA,MI,MN,MO,NC,ND,NL,NY,OH,PA,SC,TN,TX,UT,VA,WA,WI,WV, OUS: Australia, China, India, Israel, Romania, Singapore, Thailand, United Kingdom, Switzerland, Spain, Germany, Belgium,
Affected count
177 Systems
Manufactured in
826 Coal Creek Cir, N/A, Louisville, CO, United States
Products
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2330-2020Don't want to check this manually?
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