Medtronic Navigation, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2330-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 5, 2019

Date Posted: June 17, 2020

Recall Number: Z-2330-2020

Event ID: 85387

Reason for Recall:

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)]

Status: Ongoing

Product Quantity: 177 Systems

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,

Voluntary or Mandated:

Voluntary: Firm initiated