FDA Medical Device Recalls (openFDA)
Blue Belt Technologies, Inc: Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
- Recall number
- Z-0041-2024
- 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
- Status
- Open, Classified
- Initiated
- 2023-09-07
- Posted
- 2023-10-05
- Terminated
- not on file
- Reason
- 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
- 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
- 56 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689
- 510(k) numbers
- ["K231963"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3016090213
- Firm city
- Pittsburgh
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28