NovoCut CTX-C001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00853541006129), received between Oct 4, 2022 and Apr 13, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, AFTER THE IMPLANTATION OF THE FIRST FAST-FIX FLEX, THE SUTURE WAS SNAPPED, WHEN ONE NOVOCUT WAS INSERTED INTO THE JOINT WITH THE SUTURE LOADED OVER THE TIP. THE PROCEDURE WAS RESUMED, AFTER A 5-MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859686 ↗
• MalfunctionMar 18, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR SURGERY, THE NOVOCUT SUTURE MANAGER WAS UNABLE TO CLEANLY CUT THE SUTURE TAIL OF THE FAST-FIX FLEX, LEADING TO STRAGGLES EDGES AND THE FAST-FIX FLEX IMPLANTS HAD TO BE REMOVED. BOTH IMPLANTS WERE REMOVED FROM INSIDE THE PATIENT USING ARTHROSCOPIC GRASPER TO PULL IT BACK THROUGH THE MENISCUS. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE S+N KNOT PUSHER/SUTURE CUTTER WAS USED FOR FURTHER FAST-FIX ANCHOR PLACEMENT. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21631882 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY SIX (6) MONTHS AFTER AN ACL + MENISCAL ROOT REPAIR PROCEDURE PERFORMED ON (B)(6) 2022, WHERE A NOVOCUT SUTURE MANAGER WAS USED; A PATIENT EXPERIENCED SEVERAL ADVERSE EVENTS ON DIFFERENT DATES: ON (B)(6) 2024 THE PATIENT HAD SIGNIFICANT PAIN, REDUCED RANGE OF MOTION AND INABILITY TO REACH FULL FLEXION DUE TO CYCLOPS LESION, THESE AFFECTIONS WERE TREATED WITH PHYSICAL THERAPY; HOWEVER, THERE WERE NOT RESOLVED. FURTHERMORE, THE PATIENT PRESENTED SIGNIFICANT SWELLING DUE TO CYCLOPS LESION, FOR WHICH AN MRI WAS PERFORMED. ASIDE FROM THE ISSUES MENTIONED, ON (B)(6) 2024, THE PATIENT HAD FIXED FLEXION DEFORMITY WITH INABILITY TO REHAB THE DEFICIT, THEREFORE, AN ARTHROSCOPY AND DEBRIDEMENT OF CYCLOPS LESION AND NOTCHPLASTY WERE PERFORMED ON (B)(6) 2024. THE PATIENT OUTCOME IS RESOLVED/RECOVERED.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Musculoskeletal problem

  MAUDE report 19332608 ↗
• InjuryApr 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A KNEE ARTHROSCOPY, USING ONE (1) NOVOCUT SUTURE, THE PATIENT EXPERIENCED PAIN AND SWELLING IN THE RIGHT KNEE, AND THE PATIENT REPORTED FEELING A LUMP INSIDE THE RIGHT KNEE. THE PATIENT WAS TREATED ON AN ADDITIONAL SURGERY AND IS NOT RECOVERED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16748741 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN ARTHROSCOPY USING A NOVOCUT SUTURE, THE PATIENT EXPERIENCED A TWISTING INJURY TO THE RIGHT KNEE. A LARGE DISPLACED FRAGMENT OF LATERAL MENISCUS TEAR WAS NOTED ON MRI. THE PATIENT WAS TREATED BY CONSERVATIVE MANAGEMENT. THE ISSUE IS RESOLVING.

  Patient problems: Laceration(s)

  MAUDE report 15540073 ↗