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U.S. Department of Health and Human Services

Class 2 Device Recall REAL INTELLIGENCE CORI Welcome Box USA

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  Class 2 Device Recall REAL INTELLIGENCE CORI Welcome Box USA see related information
Date Initiated by Firm September 07, 2023
Date Posted October 05, 2023
Recall Status1 Open3, Classified
Recall Number Z-0041-2024
Recall Event ID 93046
510(K)Number K231963  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5)
Product Number: ROB10299
Code Information UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689
Recalling Firm/
Manufacturer		 Blue Belt Technologies, Inc
2875 Railroad St
Pittsburgh PA 15201
Manufacturer 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
FDA Determined
Cause 2		 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 FieldActions@smith-nephew.com. 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: FieldActions@smith-nephew.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = Blue Belt Technologies, Inc.
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