Z-2330-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- December 5, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 177 Systems
Product Description
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 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,
Code Information
All Lots