CORI ROB10100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556809600), received between Apr 23, 2024 and Mar 14, 2026 — classified as 3 malfunctions.

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

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, 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 ↗