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

Recall date

December 5, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2330-2020

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

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,

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)]

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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