Company: Blue Belt Technologies, Inc
Date of Enforcement Report: 6/11/2024
Class II
PRODUCT
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.
Recall Number:
Z-2135-2024
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Blue Belt Technologies, Inc
VOLUME OF PRODUCT IN COMMERCE:
916 units
DISTRIBUTION:
Nationwide Foreign: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, UK
