FDA Enforcement
Class II
Ongoing
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Recall: Z-0708-2024
·
Reported January 17, 2024
Enforcement
- Recall Number
- Z-0708-2024
- Event ID
- 93620
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Blue Belt Technologies, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 17, 2024
- Initiation Date
- November 13, 2023
- Classification Date
- January 11, 2024
- Address
- 2875 Railroad St, Pittsburgh, PA, 15201, United States
Description
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Reason
Possibility that the user is unable to resolve drill disconnection error messages.
Code Info
UDI-DI: 00885556757321 and 00885556780886; Serial No. SN00001 through SN001202, SN500001 through SN502583.
Distribution
Domestic: Nationwide Distribution.
Quantity
1859 units