Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB102
Summary
The FDA issued a Class II for Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software versi by Blue Belt Technologies, Inc. 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 degree.
Details
Source
Device Recall
External ID
Z-0041-2024
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Lot/Code Info: UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689
Quantity Affected: 56 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-07
Company
Pittsburgh, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Blue Belt Technologies, Inc has 14 FDA actions in our database, including 3 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Blue Belt Technologies, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Blue Belt Technologies, Inc have FDA actions?
Blue Belt Technologies, Inc has 14 FDA actions in our database, including 3 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0041-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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