FDA recall Z-2330-2020

Product

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

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)]

Distribution

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,

Key facts

Status

Ongoing

Initiation date

2019-12-05

Report date

2020-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louisville, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2330-2020