Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software Recalled by Blue Belt Technologies, Inc Due to CORI software was missing a planning stage that...

Date: September 7, 2023
Company: Blue Belt Technologies, Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Blue Belt Technologies, Inc directly.

Affected Products

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

Quantity: 56 units

Why Was This 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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Blue Belt Technologies, Inc

Blue Belt Technologies, Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report