Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2330-2020

December 05, 2019

Class II

Product summary

Firm
Medtronic Navigation, Inc.
Event
Event 85387
Status
Ongoing
Classification
Class II
Quantity
177 Systems
Official record key
device-enforcement:Z-2330-2020

Official wording

Reason: 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)]

Code information: All Lots

Distribution pattern: 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,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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)]