Oct

2023

FDA Recall: Software Missing Planning Stage When Definition is Outside of Reference Range

Company: Blue Belt Technologies, Inc
Date of Enforcement Report: 10/05/2023
Class II

PRODUCT

Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

Recall Number:

Z-0041-2024

REASON:

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

RECALLING FIRM/MANUFACTURER:

Blue Belt Technologies, Inc

VOLUME OF PRODUCT IN COMMERCE:

56 units

DISTRIBUTION:

US Nationwide distribution.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Software Missing Planning Stage When Definition is Outside of Reference Range

Allison Pate

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