Food, drugs, devices › Blue Belt Technologies, Inc
Device recall: CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing softw
Blue Belt Technologies, Inc (Pittsburgh, PA) initiated this device recall on 7 May 2024; FDA lists 1 product record under event 94635, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Blue Belt Technologies, Inc has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Blue Belt Technologies, Inc, Pittsburgh, PA.
Reason for recall
"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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real… | 916 units | Class II | Ongoing | 19 Jun 2024 |
Context
Other enforcement events for Blue Belt Technologies, Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Nov 2023 | CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S | Device | Class II | 1 |
| 7 Sep 2023 | Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB1029 | Device | Class II | 1 |
All 3 events for Blue Belt Technologies, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Foreign: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.