Real Intelligence CORI RI — Class II medical device recall Z-0041-2024
Ongoing recall by Blue Belt Technologies, Inc, reported 2023-10-11, distributed nationwide. CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of t
| Recall number | Z-0041-2024 |
|---|---|
| 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 | 2023-09-07 |
| Classified | 2023-10-05 |
| Reported by FDA | 2023-10-11 |
| Distributed | Nationwide (US) |
| Quantity | 56 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00885556773338 |
| Lot numbers | 51108475, 51108689, 51141585 |
Product
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Reason for recall
CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis
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-0041-2024. 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.