Pittsburgh, PA, United States
Blue Belt Technologies, Inc recalls
3 recalls recorded since 2018, most recently on 7 May 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 May 2024
- Reason
- CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay
- Distribution
- Nationwide Foreign: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2135-2024
- CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures du
Ongoing Class II Medical devices
- Recall started
- 13 November 2023
- Reason
- Possibility that the user is unable to resolve drill disconnection error messages.
- Distribution
- Domestic: Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0708-2024
- CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Ongoing Class II Medical devices
- Recall started
- 7 September 2023
- 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
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0041-2024
- Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.