Z-0041-2024Class II

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

Name: Z-0041-2024 Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product...
Creator: Blue Belt Technologies, Inc
Published: 2023-09-07
License: https://open.fda.gov/license/

Blue Belt Technologies, Inc. / initiated 2023-09-07 / Open, Classified / root cause: software

FDA source

Blue Belt Technologies, Inc began a recall of Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299 on 2023-09-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0041-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-07
Posted: 2023-10-05
Recalling firm: Blue Belt Technologies, Inc.
Product: Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Product code: OLO Orthopedic Stereotaxic Instrument
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
Root cause tag: software
FDA root cause: Software Design Change
Action: Smith & Nephew, Inc. (Blue Belt Technologies) issued Urgent Medical Device Correction Notice (C-2023-08) on September 7, 2023 via overnight mail. Letter states reason for recall, health risk and action to take: Required Actions for user/hospital: 1. Complete Correction Notice Acknowledgement Form and submit to [email protected]. 2. Prior to use of software, contact your sales representative to update settings. 3. Upon completion of settings update, you may use the CORI Surgical System until the software update is deployed. 4. A Smith & Nephew Robotics Representative will be deployed to your site to implement a new software version to correct the issue once it is available. Email: [email protected] Actions for Smith & Nephew Representatives 1. Work with customer to update CORI settings to prevent incorrect configuration. 2. Complete the attached Correction Notice Acknowledgement Form. 3. Upon completion of software upgrade, submit CORI In-Field Service Record to Field Action Team.
Quantity in commerce: 56 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0041-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0041-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-05

Product code OLO

K231963Class IIReal Intelligence™ Cori™Blue Belt Technologies, Inc. / cleared 2023-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)