CORI REAL INTELLIGENCE Robotic Drill…

Date

Jan. 17, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Blue Belt Technologies, Inc

Product

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

Reason

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

Distribution pattern

Domestic: Nationwide Distribution.

Quantity

1859 units

Codes and lots

UDI-DI: 00885556757321 and 00885556780886; Serial No. SN00001 through SN001202, SN500001 through SN502583.

Recall started

Nov. 13, 2023

Device type

Orthopedic Stereotaxic Instrument

Root cause (FDA)

Device Design

What the company told customers

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.

Recall number

Z-0708-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0708-2024. The agency record governs; check it and the company before acting.