Real Intelligence CORI knee surgery software missing planning stage
Real Intelligence CORI RI.KNEE v2.0 surgical planning software is being recalled due to a missing planning stage in cases with significant knee deformation. Affected units nationwide should not be used without verification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving surgical planning software with a missing functionality that could affect patient care. No illnesses or injuries have been reported, making the hazard theoretical rather than confirmed.
Plain-English summary
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) surgical planning software version 2.0 (2.0.0.5) is being recalled by Blue Belt Technologies, Inc. 56 units have been distributed nationwide.
The software contains a missing planning stage that occurs when a surgeon chooses to define the femoral rotational reference via the posterior condylar axis in cases of significant knee deformation (outside the normal range of 3 degrees valgus to 7 degrees varus). This missing stage could result in incomplete surgical planning data.
No illnesses or injuries related to this defect have been reported. Surgical facilities using this software should verify surgical plans through manual review before proceeding with knee replacement procedures and should contact Blue Belt Technologies for updated software.
The recalled product
- Product
- Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
- Manufacturer
- Blue Belt Technologies, Inc
- Hazard
- software-defect
- missing-planning-stage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI: (01) 00885556773338 Lot Numbers: 51141585
- 51108475
- 51108689
Distribution
Distributed nationwide across the United States.
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