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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew REAL INTELLIGENCE" CORI" (CORI)

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 Class 2 Device Recall Smith & Nephew REAL INTELLIGENCE" CORI" (CORI)see related information
Date Initiated by FirmMay 07, 2024
Date PostedJune 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2135-2024
Recall Event ID 94635
510(K)NumberK240139 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductCORI 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
Code Information 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 SN000111 SN000158 SN000205 SN000252 SN000018 SN000065 SN000112 SN000159 SN000206 SN000253 SN000019 SN000066 SN000113 SN000160 SN000207 SN000254 SN000020 SN000067 SN000114 SN000161 SN000208 SN000255 SN000021 SN000068 SN000115 SN000162 SN000209 SN000256 SN000022 SN000069 SN000116 SN000163 SN000210 SN000257 SN000023 SN000070 SN000117 SN000164 SN000211 SN000258 SN000024 SN000071 SN000118 SN000165 SN000212 SN000259 SN000025 SN000072 SN000119 SN000166 SN000213 SN000260 SN000026 SN000073 SN000120 SN000167 SN000214 SN000261 SN000027 SN000074 SN000121 SN000168 SN000215 SN000262 SN000028 SN000075 SN000122 SN000169 SN000216 SN000263 SN000029 SN000076 SN000123 SN000170 SN000217 SN000264 SN000030 SN000077 SN000124 SN000171 SN000218 SN000265 SN000031 SN000078 SN000125 SN000172 SN000219 SN000266 SN000032 SN000079 SN000126 SN000173 SN000220 SN000267 SN000033 SN000080 SN000127 SN000174 SN000221 SN000268 SN000034 SN000081 SN000128 SN000175 SN000222 SN000269 SN000035 SN000082 SN000129 SN000176 SN000223 SN000270 SN000036 SN000083 SN000130 SN000177 SN000224 SN000271 SN000037 SN000084 SN000131 SN000178 SN000225 SN000272 SN000038 SN000085 SN000132 SN000179 SN000226 SN000273 SN000039 SN000086 SN000133 SN000180 SN000227 SN000274 SN000040 SN000087 SN000134 SN000181 SN000228 SN000275 SN000041 SN000088 SN000135 SN000182 SN000229 SN000276 SN000042 SN000089 SN000136 SN000183 SN000230 SN000277 SN000043 SN000090 SN000137 SN000184 SN000231 SN000278 SN000044 SN000091 SN000138 SN000185 SN000232 SN000279 SN000045 SN000092 SN000139 SN000186 SN000233 SN000280 SN000046 SN000093 SN000140 SN000187 SN000234 SN000281 SN000047 SN000094 SN000141 SN000188 SN000235 SN000282 SN000283 SN000330 SN000387 SN000434 SN000481 SN000528 SN000284 SN000331 SN000388 SN000435 SN000482 SN000529 SN000285 SN000332 SN000389 SN000436 SN000483 SN000530 SN000286 SN000333 SN000390 SN000437 SN000484 SN000531 SN000287 SN000334 SN000391 SN000438 SN000485 SN000532 SN000288 SN000335 SN000392 SN000439 SN000486 SN000533 SN000289 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SN001049 SN001096 SN000862 SN000909 SN000956 SN001003 SN001050 SN001097 SN000863 SN000910 SN000957 SN001004 SN001051 SN001098 SN000864 SN000911 SN000958 SN001005 SN001052 SN001099 SN000865 SN000912 SN000959 SN001006 SN001053 SN001100 SN000866 SN000913 SN000960 SN001007 SN001054 SN001101 SN000867 SN000914 SN000961 SN001008 SN001055 SN001102 SN000868 SN000915 SN000962 SN001009 SN001056 SN001103 SN000869 SN000916 SN000963 SN001010 SN001057 SN001104 SN000870 SN000917 SN000964 SN001011 SN001058 SN001105 SN000871 SN000918 SN000965 SN001012 SN001059 SN001106 SN000872 SN000919 SN000966 SN001013 SN001060 SN001107 SN000873 SN000920 SN000967 SN001014 SN001061 SN001108 SN000874 SN000921 SN000968 SN001015 SN001062 SN001109 SN000875 SN000922 SN000969 SN001016 SN001063 SN001110 SN000876 SN000923 SN000970 SN001017 SN001064 SN001111 SN000877 SN000924 SN000971 SN001018 SN001065 SN001112 SN000878 SN000925 SN000972 SN001019 SN001066 SN001113 SN000879 SN000926 SN000973 SN001020 SN001067 SN001114 SN000880 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SN001086 SN001257 SN000899 SN000946 SN000993 SN001040 SN001087 SN001258 SN000900 SN000947 SN000994 SN001041 SN001088 SN001259 SN000901 SN000948 SN000995 SN001042 SN001089 SN001260 SN000902 SN000949 SN000996 SN001043 SN001090 SN001261 SN000903 SN000950 SN000997 SN001044 SN001091 SN001262 SN001263 SN001310 SN001357 SN001404 SN001264 SN001311 SN001358 SN001265 SN001312 SN001359 SN001266 SN001313 SN001360 SN001267 SN001314 SN001361 SN001268 SN001315 SN001362 SN001269 SN001316 SN001363 SN001270 SN001317 SN001364 SN001271 SN001318 SN001365 SN001272 SN001319 SN001366 SN001273 SN001320 SN001367 SN001274 SN001321 SN001368 SN001275 SN001322 SN001369 SN001276 SN001323 SN001370 SN001277 SN001324 SN001371 SN001278 SN001325 SN001372 SN001279 SN001326 SN001373 SN001280 SN001327 SN001374 SN001281 SN001328 SN001375 SN001282 SN001329 SN001376 SN001283 SN001330 SN001377 SN001284 SN001331 SN001378 SN001285 SN001332 SN001379 SN001286 SN001333 SN001380 SN001287 SN001334 SN001381 SN001288 SN001335 SN001382 SN001289 SN001336 SN001383 SN001290 SN001337 SN001384 SN001291 SN001338 SN001385 SN001292 SN001339 SN001386 SN001293 SN001340 SN001387 SN001294 SN001341 SN001388 SN001295 SN001342 SN001389 SN001296 SN001343 SN001390 SN001297 SN001344 SN001391 SN001298 SN001345 SN001392 SN001299 SN001346 SN001393 SN001300 SN001347 SN001394 SN001301 SN001348 SN001395 SN001302 SN001349 SN001396 SN001303 SN001350 SN001397 SN001304 SN001351 SN001398 SN001305 SN001352 SN001399 SN001306 SN001353 SN001400 SN001307 SN001354 SN001401 SN001308 SN001355 SN001402 SN001309 SN001356 SN001403
Recalling Firm/
Manufacturer		 Blue Belt Technologies, Inc
2875 Railroad St
Pittsburgh PA 15201
For Additional Information ContactDavid Snyder
978-749-1440
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Under Investigation by firm
ActionSmith & 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.
Quantity in Commerce916 units
DistributionNationwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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