# FDA recall Z-0041-2024

> **Blue Belt Technologies, Inc** · Class II · device recall initiated 2023-09-07.

## 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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0041-2024
- **Recalling firm:** Blue Belt Technologies, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-07
- **Report date:** 2023-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pittsburgh, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0041-2024

## Citation

> AI Analytics. FDA recall Z-0041-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0041-2024. Source: US FDA. Licensed CC0.

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