CORI Surgical System (Blue Belt) – Marker Registration Error (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Blue Belt Technologies, Inc
Lot Codes / Batch Numbers
UDI-DI: (1) ROB10000t 00885556755068, (2) ROB10024 00885556757420
Products Sold
UDI-DI: (1) ROB10000t 00885556755068; (2) ROB10024 00885556757420; (3) ROB10197 00885556796849 Serial Numbers: SN000001 SN000048 SN000095 SN000142 SN000189 SN000236 SN000002 SN000049 SN000100 SN000143 SN000190 SN000237 SN000003 SN000050 SN000101 SN000144 SN000191 SN000238 SN000004 SN000051 SN000102 SN000145 SN000192 SN000239 SN000005 SN000052 SN000103 SN000146 SN000193 SN000240 SN000006 SN000053 SN000096 SN000147 SN000194 SN000241 SN000007 SN000054 SN000097 SN000148 SN000195 SN000242 SN000008 SN000055 SN000098 SN000149 SN000196 SN000243 SN000009 SN000056 SN000099 SN000150 SN000197 SN000244 SN000010 SN000057 SN000104 SN000151 SN000198 SN000245 SN000011 SN000058 SN000105 SN000152 SN000199 SN000246 SN000012 SN000059 SN000106 SN000153 SN000200 SN000247 SN000013 SN000060 SN000107 SN000154 SN000201 SN000248 SN000014 SN000061 SN000108 SN000155 SN000202 SN000249 SN000015 SN000062 SN000109 SN000156 SN000203 SN000250 SN000016 SN000063 SN000110 SN000157 SN000204 SN000251 SN000017 SN000064 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Blue Belt Technologies, Inc is recalling CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeo due to CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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 FieldActions@smith-nephew.com. 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026