CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence CORI (3) ROB10197 CORI STARTER KIT - UNIVERSAL Note: the three product numbers cover the three different configurations in which the CORI Console is sold

CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay

Smith & Nephew (Blue Belt wholly owned subsidiary of Smith & Nephew, Inc.) issued Urgent Medical Device Correction Notice C-2024-03 notification on May 7, 2024. Letter states reason for recall, health risk and action to take: Required Actions for user/hospital: 1. Please see attached IFU Addendum for troubleshooting tips and notes to enhance the consistency of visibility of the markers and tracking arrays. This IFU Addendum can be found at https://ifu.smith-nephew.com/ by searching IFU number 1000264245. 2. Complete Correction Notice Acknowledgement Form and submit to [email protected]. 3. A Smith & Nephew Robotics Representative will be deployed to your site to implement a new software version to correct the issue once it is available.