REAL INTELLIGENCE recallZ-0708-2024 · Blue Belt Technologies, Inc · initiated Nov 13, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Blue Belt Technologies, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Possibility that the user is unable to resolve drill disconnection error messages.
FDA root cause category: Device Design
What the company is doing
The recalling firm sent an Urgent Medical Device Recall/Correction notice, dated 11/13/23, by mail to consignees. The notice informed consignees that they may continue to use affected devices as is provided that they ensure the backup Robotics Instrument Tray is available during surgery and to review the CORI Surgical System User Manual, which provides instructions for solving error messages. If consignees are unable to resolve the error messages, they should be prepared to convert to manual surgical procedure following the instructions in Appendix D: Recovery Procedure Guidelines of the CORI Surgical System User Manual. In accordance with routine servicing, consignees should return the CORI drill after 75 uses for servicing, during which the recalling firm will make the hardware update required to correct this recall event. Consignees are asked to contact their Account Representative to report pervasive drill disconnection error messages. Completed acknowledgement forms are to be returned to the recalling firm by email at [email protected]. Questions are to be directed by email to [email protected] or to your Account Representative.
Recall details
- Recall number
- Z-0708-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 13, 2023
- Posted by the FDA
- Jan 11, 2024
- Recalling firm
- Blue Belt Technologies, Inc
- Quantity
- 1859 units
- Product code
- OLO
- FDA submissions
- K231963
- Distribution
- Domestic: Nationwide Distribution.
Product description
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Code information (models, lots, serial numbers)
UDI-DI: 00885556757321 and 00885556780886; Serial No. SN00001 through SN001202, SN500001 through SN502583.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- REAL INTELLIGENCE ROB10013SSmith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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