CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in…
Medical device recall Z-2135-2024. Published in FDA’s Enforcement Report on Jun 19, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 19, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 916 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
916 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,992 characters
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…
FDA’s list runs to 11,540 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 7, 2024.
- FDA classified it on Jun 11, 2024.
- FDA’s Enforcement Report published it on Jun 19, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Blue Belt Technologies, Inc, of Pittsburgh, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 11,540 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.