Recall Z-0708-2024 · OLO Orthopedic Stereotaxic Instrument
Blue Belt Technologies, Inc
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
| Date | Jan 11, 2024 (initiated Nov 13, 2023) |
| Status | Open, Classified |
| 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 |
| Quantity | 1859 units |
| Distribution | Domestic: Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231963 | REAL INTELLIGENCE CORI Blue Belt Technologies, Inc., Aug 1, 2023 |