Recall Z-2135-2024 · OLO Orthopedic Stereotaxic Instrument
Blue Belt Technologies, Inc
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence CORI (3) ROB10197 CORI STARTER KIT - UNIVERSAL Note: the three product
| Date | Jun 11, 2024 (initiated May 7, 2024) |
| Status | Open, Classified |
| Reason | CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay |
| Root cause | Under Investigation by firm |
| Action | Smith & Nephew (Blue Belt wholly owned subsidiary of Smith & Nephew, Inc.) issued Urgent Medical Device Correction Notice C-2024-03 notification on May 7, 2024. Letter states reason for recall, health risk and action to take: Required Actions for user/hospital: 1. Please see attached IFU Addendum for troubleshooting tips and notes to enhance the consistency of visibility of the markers and tracking arrays. This IFU Addendum can be found at https://ifu.smith-nephew.com/ by searching IFU number 1000264245. 2. Complete Correction Notice Acknowledgement Form and submit to FieldActions@smith-nephe |
| Quantity | 916 units |
| Distribution | Nationwide Foreign: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K240139 | Real Intelligence CORI Blue Belt Technologies, Inc., Mar 18, 2024 |