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

FDA device recall Z-0708-2024 · posted 2024-01-11 · Open, Classified

Recall details

Recalling firm

Blue Belt Technologies, Inc

Reason for recall

Possibility that the user is unable to resolve drill disconnection error messages.

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.

Root cause

Device Design

Status

Open, Classified

Product code

OLO

Quantity affected

1859 units

Distribution

Domestic: Nationwide Distribution.

Date initiated

2023-11-13

Date posted

2024-01-11

Location

Pittsburgh, PA

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