Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Reported: October 11, 2023 Initiated: September 7, 2023 #Z-0041-2024
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
Details
- Recalling Firm
- Blue Belt Technologies, Inc
- Units Affected
- 56 units
- Distribution
- US Nationwide distribution.
- Location
- Pittsburgh, PA
Frequently Asked Questions
What product was recalled? ▼
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299. Recalled by Blue Belt Technologies, Inc. Units affected: 56 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-0041-2024.
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