Z-0708-2024Class II

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

Name: Z-0708-2024 CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Creator: Blue Belt Technologies, Inc
Published: 2023-11-13
License: https://open.fda.gov/license/

Blue Belt Technologies, Inc. / initiated 2023-11-13 / Open, Classified / root cause: design

FDA source

Blue Belt Technologies, Inc began a recall of CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S on 2023-11-13. FDA classified it as Class II and gives the reason as "Possibility that the user is unable to resolve drill disconnection error messages". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0708-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-13
Posted: 2024-01-11
Recalling firm: Blue Belt Technologies, Inc.
Product: CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Possibility that the user is unable to resolve drill disconnection error messages.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1859 units
Distribution: Domestic: Nationwide Distribution.
Product codes and lots: UDI-DI: 00885556757321 and 00885556780886; Serial No. SN00001 through SN001202, SN500001 through SN502583.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0708-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0708-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-11

Product code OLO

K231963Class IIReal Intelligence™ Cori™Blue Belt Technologies, Inc. / cleared 2023-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)