NOVOSTITCHRecalls & reported problems across all models

We found 5 models of NOVOSTITCH by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 149 adverse event reports in the FDA's MAUDE database, received between Nov 28, 2018 and May 28, 2026 — classified as 71 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Break” (94 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. 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

Most reported NOVOSTITCH problems

NOVOSTITCH models

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

• NOVOSTITCH CTX-A003

  Suture, Nonabsorbable, Synthetic, Polyethylene
  98 reports
• NOVOSTITCH CTX-A004

  Suture, Nonabsorbable, Synthetic, Polyethylene
  25 reports
• NOVOSTITCH CTX-R001

  Suture, Nonabsorbable, Synthetic, Polyethylene
  23 reports
• NOVOSTITCH CTX-R002

  Suture, Nonabsorbable, Synthetic, Polyethylene
  2 reports
• NovoStitch CTX-A002

  Suture, Nonabsorbable, Synthetic, Polyethylene
  1 report

Recent NOVOSTITCH adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, NOVOSTITCH SUTURE BROKE AFTER THE DEPLOYMENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318561 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, NOVOSTITCH SUTURE BROKE AFTER THE DEPLOYMENT. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318425 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, THE NOVOSTITCH SUTURE BROKE AFTER DEPLOYMENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311332 ↗
• MalfunctionFeb 18, 2026Break

  IT WAS REPORTED THAT, DURING A LEEP PROCEDURE, A NOVOSTITCH WAS DEPLOYED AND IT WAS NOTICED THAT THE TIP CAME LOOSE AND BROKE AWAY FROM THE POLE UPON REMOVAL FROM THE PATIENT. ONE PIECE WAS ABLE TO BE RECOVERED. X-RAYS WERE TAKEN BY PROTOCOL AND NO FOREIGN BODIES WERE RETAINED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, NO SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381611 ↗
• MalfunctionJan 27, 2026Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE LOWER JAW OF A NOVOSTITCH DEVICE WOULD NOT MOVE, AND THE TIP EASILY BROKE OFF, MAKING IT UNUSABLE EVEN AFTER REPLACING THE CARTRIDGE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. 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 24190799 ↗
• MalfunctionSep 29, 2025Break; Break

  IT WAS REPORTED THAT, DURING A MENISCAL ARTHROSCOPIC PROCEDURE, IT WAS NOTICED DURING POSITIONING OF THE SECOND SUTURE THAT THE NOVOSTITCH WAS BROKEN. NO PARTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23166956 ↗
• InjurySep 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON REGISTRY REVIEW "2025 NEW ZEALAND ACL REGISTRY IMPLANT REPORT", AN UNKNOWN NUMBER OF PATIENTS HAD A FAILURE OF THE IMPLANTS AFTER AN ACL PROCEDURE WHERE TWO (2) NOVOSTITCH PRO DEVICES WERE USED. PATIENTS REQUIRED REVISION SURGERY. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23062872 ↗
• MalfunctionSep 12, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A REPAIR OF A RADIAL MENISCAL TEAR, THE LATERAL JAW OF THE NOVOSTITCH PRO MEN WAS STIFF TO DEPLOY. THE SURGEON WAS ABLE TO DEPLOY FIRST PASS, BUT THE SECOND PASS DID NOT CAPTURE. WHEN THE CARTRIDGE WAS RELOADED, IT WAS FOUND THAT THE NEEDLE HAD SEPARATED FROM FIRST CARTRIDGE AND FELL OUTSIDE THE PATIENT, THERE WAS NO REMNANTS OF THE NEEDLE LEFT IN PATIENT. THERE WAS CHANGE IN THE SURGICAL TECHNIQUE AS SURGEON WENT TO INSIDE OUT WITH OUR MENISCAL STITCHER SET, SECURING WITH A COMBINATION OF FAST FIX FLEX AND FAST FIX 360, WITH A DELAY LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042544 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR, THE TRAP DOOR OF THE NOVOSTICTCH DEVICE WHICH THE SUTURE PASSES HAS BROKEN OFF INSIDE THE PATIENT WHILE DEPLOYING. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT USING A GRASPER. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22985292 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT, DURING A RADIUS MENISCUS TEAR REPAIR, THE SURGEON TIED THE KNOT AND REPAIRED THE MENISCUS TEAR BUT AFTER A WHILE THE NOVOSTITCH CARTRIDGE 2-0 SUTURE BROKE, AND THE REPAIR SITE WAS OPENED AGAIN. THE SUTURE WAS REMOVED FROM THE PATIENT WITH A GRASPER. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669071 ↗
• MalfunctionJun 30, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A REPAIR OF A RADIAL TEAR OF THE MENISCUS, AFTER PASSING THE FIRST SUTURE, RELOADING AND PASSING HIS SECOND SUTURE, THE GUN OF THE NOVOSTITCH SEEMED TO JAM ON THE MENISCUS. WHEN THE GUN FINALLY RELEASED, A PIECE OF NEEDLE WAS LEFT BEHIND IN THE MENISCUS. THE BROKEN FRAGMENT WAS REMOVED FROM INSIDE THE PATIENT WITH GRASPERS AND THE MENISCAL REPAIR WAS COMPLETED WITH ALL INSIDE DEVICES. 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 22366603 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE NOVOSTITCH PRO MENISCAL REPAIR SYSTEM'S FIRST LOAD WAS CAPTURED PROPERLY, BUT THE CARTRIDGE BROKE IN HALF PRIOR TO THE SECOND CAPTURE WHILE STILL ATTACHED TO THE NOVOSTITCH HANDLE AS THE DOCTOR WAS ATTEMPTING INSERTION INTO THE MENISCUS, RESULTING IN AN INCOMPLETE REPAIR. THE SURGERY WAS COMPLETED USING A BACKUP DEVICE INSTEAD, A FIRSTPASS MINI. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NOTHING FELL OFF INSIDE THE PATIENT'S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22353141 ↗
• MalfunctionMay 15, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A POSTERIOR MENISCUS REPAIR PROCEDURE, THE NOVOSTITCH CARTRIDGE 2-0 FIRST PIERCING WAS SUCCESSFUL, HOWEVER, THE SECOND PIERCING WAS NOT SUCCESSFUL, AND IT STUCK IN BETWEEN. IT WAS REMOVED FROM THE PATIENT USING A GRASPER AND AN ARTERY. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027320 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR, THE NOVOSTITCH PRO MEN THE NEEDLE TIP BROKE OFF WHILE ATTEMPTING TO PASS THE SUTURE, THE BROKEN PIECES WERE REMOVED USING ARTHROSCOPIC INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026988 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, WHEN MANEUVERING THE NOVOSTITCH INTO THE JOINT, THE SURGEON PULLED ON THE ORANGE HANDLE TO FLATTEN THE TOP JAW, IT MADE A CRACKING NOISE AND THE JAW HINGE HAD BROKEN. THERE WERE NO PIECES THAT FELL OFF OF THE DEVICE, BOTH ENDS REMAINED ATTACHED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749197 ↗

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