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FDAFDA · Food and drugs·Recall number Z-2135-2024

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

Published June 19, 2024 · Recall initiated: May 7, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Blue Belt Technologies, Inc
Distributor
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
Lot
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 SN000336 SN000393 SN000440 SN000487 SN000534 SN000290 SN000337 SN000394 SN000441 SN000488 SN000535 SN000291 SN000338 SN000395 SN000442 SN000489 SN000536 SN000292 SN000339 SN000396 SN000443 SN000490 SN000537 SN000293 SN000340 SN000397 SN000444 SN000491 SN000538 SN000294 SN000341 SN000398 SN000445 SN000492 SN000539 SN000295 SN000342 SN000399 SN000446 SN000493 SN000540 SN000296 SN000343 SN000400 SN000447 SN000494 SN000541 SN000297 SN000344 SN000401 SN000448 SN000495 SN000542 SN000298 SN000345 SN000402 SN000449 SN000496 SN000543 SN000299 SN000346 SN000403 SN000450 SN000497 SN000544 SN000300 SN000347 SN000404 SN000451 SN000498 SN000545 SN000301 SN000348 SN000405 SN000452 SN000499 SN000546 SN000302 SN000349 SN000406 SN000453 SN000500 SN000547 SN000303 SN000350 SN000407 SN000454 SN000501 SN000548 SN000304 SN000351 SN000408 SN000455 SN000502 SN000549 SN000305 SN000352 SN000409 SN000456 SN000503 SN000550 SN000306 SN000353 SN000410 SN000457 SN000504 SN000551 SN000307 SN000354 SN000411 SN000458 SN000505 SN000
Risk classification
Class II
Area (FDA)
device
Country
United States

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