FDA Medical Device Recalls (openFDA)
Blue Belt Technologies, Inc: CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
- Recall number
- Z-0708-2024
- Recalling firm
- Blue Belt Technologies, Inc
- Product
- CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
- Status
- Open, Classified
- Initiated
- 2023-11-13
- Posted
- 2024-01-11
- Terminated
- not on file
- Reason
- Possibility that the user is unable to resolve drill disconnection error messages.
- 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 fieldactions@Smith-Nephew.com. Questions are to be directed by email to fieldactions@smith-nephew.com or to your Account Representative.
- Quantity
- 1859 units
- Distribution
- Domestic: Nationwide Distribution.
- Lot, serial or model codes
- UDI-DI: 00885556757321 and 00885556780886; Serial No. SN00001 through SN001202, SN500001 through SN502583.
- 510(k) numbers
- ["K231963"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3016090213
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28