FDA recall Z-0708-2024

Blue Belt Technologies, Inc · Class II · device

Product

CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S

Reason for recall

Possibility that the user is unable to resolve drill disconnection error messages.

Distribution

Domestic: Nationwide Distribution.

Key facts

Status
Ongoing
Initiation date
2023-11-13
Report date
2024-01-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pittsburgh, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0708-2024