Recall Z-0041-2024 · OLO Orthopedic Stereotaxic Instrument
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
| Date | Oct 5, 2023 (initiated Sep 7, 2023) |
| Status | Open, Classified |
| 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 deploy |
| Quantity | 56 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231963 | REAL INTELLIGENCE CORI Blue Belt Technologies, Inc., Aug 1, 2023 |