CORI Starter Kit — Class II medical device recall Z-2135-2024
Ongoing recall by Blue Belt Technologies, Inc, reported 2024-06-19, distributed nationwide. CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) whi
| Recall number | Z-2135-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blue Belt Technologies, Inc, Pittsburgh, PA, United States |
| Recall initiated | 2024-05-07 |
| Classified | 2024-06-11 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CL, CN, CO, CY, DE, ES, FR, GB, GR, HK, IE, IL, IN, IT, JP, KR, KW, MY, NL, NO, NZ, PL, PT, SA, SE, SG, TH, TR, TW, ZA |
| Quantity | 916 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00885556755068, 00885556757420, 00885556796849 |
| Serial numbers | SN000001, SN000002, SN000003, SN000004, SN000005, SN000006, SN000007, SN000008, SN000009, SN000010, SN000011, SN000012, SN000013, SN000014, SN000015, SN000016, SN000017, SN000018, SN000019, SN000020, SN000021, SN000022, SN000023, SN000024, SN000025 and 475 more |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2135-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.