CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
This recall is currently active, issued January 11, 2024. It was issued by Blue Belt Technologies, Inc.
- Company
- Blue Belt Technologies, Inc
- Recall Initiated
- November 13, 2023
- Posted
- January 11, 2024
- Recall Number
- Z-0708-2024
- Quantity
- 1859 units
- Firm Location
- Pittsburgh, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Possibility that the user is unable to resolve drill disconnection error messages.
Distribution
Domestic: Nationwide Distribution.
Lot / Code Info
UDI-DI: 00885556757321 and 00885556780886; Serial No. SN00001 through SN001202, SN500001 through SN502583.
Root Cause
Device Design
Action Taken
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.