Recall Z-0041-2024— Blue Belt Technologies, Inc
Class II · Ongoing
Class II FDA medical device recall by Blue Belt Technologies, Inc, initiated 2023-09-07. It names one FDA 510(k) clearance: K231963. Product: Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299. 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
- Blue Belt Technologies, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-07
- Firm location
- Pittsburgh, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.