CORI RI.KNEE Software (Blue Belt) – Planning Stage Missing (2023)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.