REAL INTELLIGENCERecalls & reported problems across all models
Smith & Nephew, Inc. · 32 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one REAL INTELLIGENCE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,017
- Deaths reported
- 0
- Injuries reported
- 492
- Recalls
- 3
We found 32 models of REAL INTELLIGENCE by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 2,017 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2020 and May 15, 2026 — classified as 492 injuries, 1,525 malfunctions.
The most frequently reported specific device problem is “Unintended Application Program Shut Down” (432 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
REAL INTELLIGENCE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 7, 2024Open, Classified
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
Z-2135-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 13, 2023Open, Classified
Possibility that the user is unable to resolve drill disconnection error messages.
Z-0708-2024 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
- Sep 7, 2023Open, Classified
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
Z-0041-2024 · Root cause: Software Design Change · Recall details · FDA record ↗
Most reported REAL INTELLIGENCE problems
Device problems
- Unintended Application Program Shut Down432
- Application Program Problem: Parameter Calculation Error374
- Connection Problem326
- Fracture192
- Physical Resistance/Sticking170
- Break119
- Unintended Movement89
- Intermittent Continuity88
Patient problems
- No Clinical Signs, Symptoms or Conditions1,872
- Laceration(s)59
- No Known Impact Or Consequence To Patient45
- No Consequences Or Impact To Patient38
- No Patient Involvement22
- Unspecified Tissue Injury20
- Injury9
- Loss of Range of Motion8
REAL INTELLIGENCE models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- REAL INTELLIGENCE ROB10024Orthopedic stereotaxic instrument1 recall924 reports
- REAL INTELLIGENCE ROB10013Orthopedic stereotaxic instrument1 recall528 reports
- REAL INTELLIGENCE ROB10016Orthopedic stereotaxic instrument218 reports
- REAL INTELLIGENCE ROB10015Orthopedic stereotaxic instrument139 reports
- REAL INTELLIGENCE ROB10013SOrthopedic stereotaxic instrument1 recall2 reports
- Real Intelligence ROB10299Orthopedic stereotaxic instrument1 recall0 reports
- REAL INTELLIGENCE ROB10025Orthopedic stereotaxic instrument41 reports
- REAL INTELLIGENCE ROB10011Orthopedic stereotaxic instrument20 reports
- REAL INTELLIGENCE ROB10027Orthopedic stereotaxic instrument18 reports
- REAL INTELLIGENCE ROB10010Orthopedic stereotaxic instrument17 reports
- REAL INTELLIGENCE ROB10026Orthopedic stereotaxic instrument17 reports
- REAL INTELLIGENCE ROB10020Orthopedic stereotaxic instrument16 reports
- REAL INTELLIGENCE ROB10003Orthopedic stereotaxic instrument9 reports
- REAL INTELLIGENCE ROB10014Orthopedic stereotaxic instrument9 reports
- REAL INTELLIGENCE ROB10018Orthopedic stereotaxic instrument9 reports
- REAL INTELLIGENCE ROB10036Orthopedic stereotaxic instrument8 reports
- Real Intelligence ROB20000Orthopedic stereotaxic instrument7 reports
- REAL INTELLIGENCE ROB10012Orthopedic stereotaxic instrument6 reports
- REAL INTELLIGENCE ROB10035Orthopedic stereotaxic instrument6 reports
- REAL INTELLIGENCE ROB10017Orthopedic stereotaxic instrument5 reports
- REAL INTELLIGENCE ROB10019Orthopedic stereotaxic instrument3 reports
- REAL INTELLIGENCE ROB10021Orthopedic stereotaxic instrument2 reports
- REAL INTELLIGENCE ROB10031Orthopedic stereotaxic instrument2 reports
- Real Intelligence ROB10086Orthopedic stereotaxic instrument2 reports
- Real Intelligence ROB30001Orthopedic stereotaxic instrument2 reports
- REAL INTELLIGENCE ROB10002Orthopedic stereotaxic instrument1 report
- REAL INTELLIGENCE ROB10022Orthopedic stereotaxic instrument1 report
- REAL INTELLIGENCE ROB10033Orthopedic stereotaxic instrument1 report
- REAL INTELLIGENCE ROB10023Orthopedic stereotaxic instrument1 report
- REAL INTELLIGENCE ROB100021Orthopedic stereotaxic instrument1 report
- REAL INTELLIGENCE ROB100022Orthopedic stereotaxic instrument1 report
- REAL INTELLIGENCE ROB10024SOrthopedic stereotaxic instrument1 report
Recent REAL INTELLIGENCE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Unintended Movement
IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE ROBOTIC DRILL STOPPED BURRING JUST AT THE START OF THE DISTAL CUT. A SECOND HANDPIECE WAS TRIED BUT IT FAILED AS WELL: WHEN THEY TRIED TO ASSEMBLE THE BURR, AFTER UNLOCKING, THE BURR WOULD PUSH THE INTERNAL MECHANISM OF THE HANDPIECE, AND IT COULDN'T CAPTURE THE BURR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25184889 ↗MalfunctionMay 14, 2026Application Program Problem: Parameter Calculation Error
IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, SURGEON DISAGREED WITH THE PATIENT¿S ALIGNMENT BASED ON HIS CLINICAL JUDGEMENT, RELATIVE TO THE OUTPUT THE ROBOTIC SYSTEM WAS REPORTING. WHILE THE ROBOT SHOULD¿VE PLACED HIS FEMUR AND TIBIA IN A FEW DEGREES OF VARUS, HE CLINICALLY DETERMINED THE PATIENT¿S COMPONENTS AND OVERALL ALIGNMENT WAS VALGUS, PROMPTING HIM TO RECUT USING MANUAL INSTRUMENTATION. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177724 ↗MalfunctionMay 5, 2026Display or Visual Feedback Problem
IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, WHEN SELECTING THE TIBIAL TWIN PEG CUTTING OPTION THE SCREEN FROZE AND THE TOP OF THE TIBIA ON THE RIGHT HAND SIDE OF THE SCREEN, WHICH IS USED TO CONFIRM POSITION OF THE TIBIAL CUTTING BLOCK, COULD NOT BE SEEN. THREE ATTEMPTS WERE WERE MADE TO SHUT DOWN THE SYSTEM AND THEN TO RESUME THE CASE. HOWEVER, ON EACH ATTEMPT THE SAME PROBLEM WAS INCURRED. THE OPTION TO BURR ALL THE TIBIA WAS WORKING, BUT THE SURGEON WAS NOT HAPPY TO USE THIS CUTTING TECHNIQUE DUE TO LIMITED EXPERIENCE WITH THE SYSTEM. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089762 ↗MalfunctionMay 3, 2026Application Program Problem: Parameter Calculation Error
IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, WHEN BURRING THE DISTAL FEMUR, THE PURPLE REMOVAL ICON WAS SELECTED. IT REMOVED THE PURPLE MODEL FROM THE DISTAL FEMUR MODEL ON THE CUT SCREEN. THE SURGEON REQUESTED THE PURPLE TO BE PUT BACK, BUT EVEN WHEN MOVING THE RESECTION +1MM ON THE PLANNING SCREEN, AND MOVING THE FEMUR MEDIAL A FEW CLICKS, THE PURPLE DID NOT RETURN. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25064276 ↗MalfunctionMay 1, 2026Unintended Application Program Shut Down
IT WAS REPORTED THAT, DURING A CORI ASSISTED SURGERY, THE REAL INTELLIGENCE CORI DISPLAYED AN ¿INTERNAL ERROR¿ MESSAGE AND DID NOT ALLOW THE PROCEDURE TO BE COMPLETED. THE SURGEON THEN PROCEEDED TO COMPLETE THE PROCEDURE USING CONVENTIONAL SURGICAL TECHNIQUES. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058973 ↗MalfunctionApr 28, 2026Mechanical Jam
IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, WHILE DRILL CONNECTING, THE REAL INTELLIGENCE 5 MM CYLINDRICAL BU COULD NOT BE REMOVED FROM THE REAL INTELLIGENCE ROBOTIC DRILL. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25016593 ↗MalfunctionApr 28, 2026Application Program Problem: Parameter Calculation Error
IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED THA SURGERY, THE CORI DID NOT RECOGNIZE THE ASIS POINTS AND ACETABULUM RELATIVE TO THE PLAN. IT WAS NOT ALLOWING TO SKIP THE PELVIS AND GO ONTO "LEG SITUATION." INSTEAD, IT WAS GIVING US THE OPTION OF EITHER RE-REGISTERING THE PELVIS OR GOING RIGHT TO THE REPORT. IT IS WORTH NOTING THAT BOTH OF THESE PELVISES HAD HIGH ANTERIOR TILT NUMBERS (13+ DEGREES), SO IT WAS HARD TO GET THE ASIS POINTS REGISTERED IN THE FIRST PLACE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25013284 ↗MalfunctionApr 28, 2026Application Program Problem: Parameter Calculation Error
IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED THA SURGERY, THE CORI DID NOT RECOGNIZE THE ASIS POINTS AND ACETABULUM RELATIVE TO THE PLAN. IT WAS NOT ALLOWING TO SKIP THE PELVIS AND GO ONTO "LEG SITUATION." INSTEAD, IT WAS GIVING US THE OPTION OF EITHER RE-REGISTERING THE PELVIS OR GOING RIGHT TO THE REPORT. IT IS WORTH NOTING THAT BOTH OF THESE PELVISES HAD HIGH ANTERIOR TILT NUMBERS (13+ DEGREES), SO IT WAS HARD TO GET THE ASIS POINTS REGISTERED IN THE FIRST PLACE. THEN, TRIED TO RE-REGISTER IT FOR A SECOND TIME AND ACTUALLY GOT THE PELVIS SIDE TO REGISTER, SO WE COULD USE THE CORI FOR PELVIC NUMBERS. HOWEVER, WHEN WE TRIED TO MOVE ONTO THE LEG LENGTH / OFFSET NUMBERS SCREEN IT WOULD NOT LET US, AND WOULD AGAIN GO STRAIGHT TO REPORT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25013198 ↗MalfunctionApr 16, 2026Application Program Problem: Parameter Calculation Error
IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TSA SURGERY, WHEN TRYING TO UNLOCK THE REAL INTELLIGENCE ROBOTIC DRILL, A DISCONNECT ERROR APPEARED. THE PLUG ON THE DRILL WAS STILL HOT AFTER STERILIZED. EVENTUALLY THE TEAM WAS ABLE TO CALIBRATE AND MOVE FORWARD. LATER IN THE CASE WHEN MAPPING THE HUMERUS, THE DATA POINTS AND MODEL SEEMED TO BE JUMPING AROUND AND OFF THE MODEL. THEY WERE UNABLE TO HAVE THE MODEL TURN WHITE, SO THEY BACKED THE CASE UP TO RECOLLECT THEIR LANDMARK POINTS AND TRY AGAIN. AFTER ANOTHER UNSUCCESSFUL ATTEMPT, THEY WENT TO TRY AND BACK UP AGAIN WHICH LED TO AN INTERNAL ERROR POPPING UP AND MAKING THEM QUIT THE CASE. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, WITH MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903734 ↗MalfunctionApr 16, 2026Application Program Freezes or Fails to Launch
IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED THA SURGERY, DURING CUP NAVIGATION, THE CAMERA DID NOT SEE THE CUP IMPACTOR EVEN THOUGH IT WAS IN VIEW OF CAMERA, THE NAVIGATION SCREEN FROZE UP AND THE REP HAD TO RESTART THE REAL INTELLIGENCE CORI BECAUSE THE CONSOLE WAS FROZEN ON NAVIGATION SCREEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896987 ↗MalfunctionApr 14, 2026Unintended Application Program Shut Down
IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, MADE IT TO PRELIMINARY PLANNING SCREEN (BEFORE TAKING STRESSED RANGE OF MOTION) AND SAW THAT MORE POINTS WERE NEED ON THE FEMUR. WENT BACK TO THE FEMUR MAPPING SCREEN TO ADD THOSE POINTS AND BOTH 24" TOUCHSCREEN AND TABLET SHUT DOWN. UNABLE TO CONTINUE SO WE HAD TO RESTART THE SYSTEM AND RESUME THE CASE FROM THERE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879843 ↗MalfunctionApr 13, 2026Unintended Movement
IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, WHILE BURRING, THE REAL INTELLIGENCE ROBOTIC DRILL GUARD WOULD NOT SIT FLUSH AND BURR CLEANLY. ATTEMPTED TO TAKE OFF AND PUT BACK ON, CLEAN FOR DEBRIS WITHOUT RESOLUTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865456 ↗MalfunctionApr 5, 2026Break; Overheating of Device; Unintended Movement; Physical Resistance/Sticking
IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE ROBOTIC DRILL BEGAN TO OVERHEAT AND THEN STOPPED WORKING. THE PROCEDURE WAS CONVERTED TO A MANUAL PROCEDURE BECAUSE A BACKUP WAS NOT AVAILABLE. THE PROCEDURE WAS COMPLETED WITHOUT CONSEQUENCES FOR THE PATIENT. AFTER THE SURGERY THE DRILL DIAGNOSTIC COULD NOT BE PERFORMED, BECAUSE THE BUR WAS NOT ENGAGING ONTO THE HANDPIECE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787072 ↗MalfunctionApr 1, 2026Device Dislodged or Dislocated; Positioning Problem
IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, THE BURR WAS INSERTED PROPERLY INTO THE RI ROBOTIC DRILL ATTACHMENT AND WAS ABLE TO SUCCESSFULLY CALIBRATE AND RETRACT. HOWEVER, WHEN GOING TO DISTAL CUT, THE BURR DISENGAGED THE HANDPIECE AND FELL OUT ONTO THE STERILE FIELD. WHEN THE BURR WAS REINSERTED AND RECALIBRATED, IT WAS SITTING UP ~2MM. THE CASE WAS COMPLETED AND THE DRILL WAS TESTED AND IT PASSED THE KPC TEST. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752445 ↗MalfunctionMar 31, 2026Material Deformation; Mechanics Altered
IT WAS REPORTED THAT, DURING CORI ASSISTED SURGERY, WHILE THE BONE CUTTING STEP, IT WAS OBSERVED THAT THE BUR HEAD WAS UNABLE TO CUT THE BONE EFFECTIVELY. AN ATTEMPT WAS MADE TO REPLACE IT WITH THE ROBOTIC DRILL EXTRA. DURING THIS PROCESS, IT WAS FOUND THAT THE ROBOTIC DRILL ATTACHMENT, BECAME STUCK. THEREFORE, THE INSTRUMENT WAS TAKEN TO THE ADMIN SYSTEM AND THE LONG ATTACHMENT ASSEMBLING FUNCTION WAS USED TO UNLOCK THE COLLET. AS THE SURGEON COULD NOT WAIT FOR FURTHER TROUBLESHOOTING, IT WAS DECIDED TO CONVERT TO A CONVENTIONAL SURGICAL TECHNIQUE TO CONTINUE THE PROCEDURE. AFTER THE INSTRUMENT WAS SUCCESSFULLY REMOVED, IT WAS OBSERVED THAT THE DISTAL END OF THE ROBOTIC DRILL WAS DAMAGED. THIS WAS CASE 5. THE CASES 1¿4 PROGRESSED NORMALLY WITHOUT ANY ISSUES. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24750515 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- Coblation62 models · 2,126 reports
- TWINFIX48 models · 1,450 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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