CORIRecalls & reported problems across all models

We found 3 models of CORI by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2024 and Mar 14, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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

CORI 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.

1. 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 ↗

Most reported CORI problems

CORI models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CORI ROB10000

  Orthopedic stereotaxic instrument
  1 recall0 reports
• CORI ROB10100

  Orthopedic stereotaxic instrument
  3 reports
• CORI ROB10101

  Orthopedic stereotaxic instrument
  1 report

Recent CORI adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A TKA, AFTER THE CORI KNEE TENSIONER HAD PASSED THE CALIBRATION, IT TIMED OUT DURING GAP STRESSING MULTIPLE TIMES. THIS CONTINUED EVEN AFTER CARTRIDGE RELATED TROUBLESHOOTING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO A MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600279 ↗
• MalfunctionMay 7, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING CORI ASSISTED TKA SURGERY, THE CORI KNEE TENSIONER FAILED TO RECORD DATA WHEN TENSIONING THE JOINT. AT THE START OF THE CASE WHEN SETTING UP THE TENSIONER, THE TENSIONER CABLE WAS CONNECTED TO THE CORI, HOWEVER THE RE-USABLE COMPONENT HAD NOT BEEN CONNECTED TO THE CARTRIDGE BY THE NURSE YET. AFTER THE NURSE CONNECTED THE CARTRIDGE TO THE TENSIONER, A RECOLLECT ERROR CAME UP WHEN TRYING TO SET UP THE TENSIONER. THE TENSIONER WAS THEN DISCONNECTED FROM THE CORI UNIT AND FROM THE RE-USABLE COMPONENT AND RE-CONNECTED TO COLLECT THE STEP UP AGAIN, ANOTHER RE-CONNECT ERROR CAME UP. THE TENSIONER WAS UNPLUGGED AND REPLUGGED AGAIN AND ANOTHER ATTEMPT WAS MADE, THIS TIME THE SETUP COLLECTED AS NORMAL. HOWEVER, WHEN IT CAME TO USE THE TENSIONER IN THE JOINT, DR. PARKER REPORTED THE HE WAS SQUEEZING THE TENSIONER HOWEVER NOTHING WAS BEING COLLECTED ON THE SCREEN. THE DEVICE WAS UNPLUGGED AND REPLUGGED, THIS DID NOT SOLVE THE ISSUE. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY BY MANUAL PROCEDURE. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259449 ↗
• MalfunctionApr 23, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING CORI ASSISTED TKA SURGERY, THE CORI KNEE TENSIONER KEPT DISCONNECTING. FOR 2 SECONDS IT WOULD ACT AS THOUGHT, THE PIECE WAS CONNECTED PROPERLY TO THE SYSTEM AND THEN WOULD DISCONNECT. THE TECH DISCONNECTED AND RECONNECTED THE REUSABLE AND DISPOSABLE PIECES BUT THIS DID NOT WORK. TECH ALSO TRIED SWITCHING USB PORTS BUT WAS UNSUCCESSFUL AS WELL. FINALLY, THE GAP ASSESSMENT WAS PERFORMED WITH MANUALLY AND THE SURGERY WAS COMPLETED WITH CORI AFTER A NON-SIGNIFICANT DELAY. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164806 ↗
• MalfunctionJan 3, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING CORI ASSISTED TKA SURGERY, THE CORI KNEE TENSIONER CARTRIDGE DID NOT FIT INTO TENSIONER. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY WITH MANUAL GAP ASSESSMENT (MEANING, THE TENSIONER WAS NOT USED), BUT THE PROCEDURE WAS CONCLUDED WITH CORI. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436913 ↗

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
• REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
• Coblation62 models · 2,126 reports