FDA Device Recall Z-0041-2024: Blue Belt Technologies, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0041-2024.

Recall Res Number

Z-0041-2024

Recalling Firm / Manufacturer

Blue Belt Technologies, Inc

FEI Number

3016090213

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2023-09-07

Date Posted

2023-10-05

Date Terminated

N/A

Product Code

OLO

Event Number

93046

Product Quantity

56 units

Product Description Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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

Action Details 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.

Distribution Pattern US Nationwide distribution.

Code Information / Serial Numbers UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689

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Medical Device Recall: Z-0041-2024

Recall Parameters & Description

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