STRATAFIX SXPP2B436Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10705031464575), received between Apr 13, 2022 and Apr 16, 2026 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Material Separation” (43 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 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON 20-JAN-2026 AND A BARBED SUTURE WAS USED. POST-OP, ON (B)(6) 2026, THE BARBED SUTURE MIGRATED AWAY FROM THE INCISION AND EXITED THROUGH THE SKIN MEDIAL TO THE INCISION SITE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 24904081 ↗
• MalfunctionApr 16, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR TOTAL HIP REPLACEMENT ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE WAS NOT ABSORBING AND MIGRATED FROM THE INCISION. THE PATIENT WAS ABLE TO EXTRACT THE WHOLE SUTURE FROM THE INNER PART OF HER THIGH 4-5 WEEKS POST OPERATION. IT WAS REPORTED THAT (B)(6) 2025, WAS WHEN THE SUTURE WAS MIGRATING AND THE PATIENT REPORTED IT TO THE PHYSICIAN. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 24904080 ↗
• MalfunctionApr 16, 2026Failure to Degrade

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. POST-OP ON (B)(6) 2026, THE BARBED SUTURE MIGRATED AWAY FROM THE INCISION AND EXITED THROUGH THE SKIN MEDIAL TO THE INCISION SITE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 24897214 ↗
• MalfunctionApr 7, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP THAT THE NEEDLE WAS POPPING OFF SUTURE IN MIDDLE OF OPERATION. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807237 ↗
• MalfunctionMar 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING ORTHOPEDIC SURGERY THE NEEDLE POP OFF ON THE SUTURE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611264 ↗
• MalfunctionJan 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP, THAT THE NEEDLE POPPED OFF ONCE AGAIN. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130462 ↗
• MalfunctionJan 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY THE SALES REP, THAT THE NEEDLE POPPED OFF ONCE AGAIN. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130202 ↗
• MalfunctionJan 8, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE NEEDLE IS KEEP POOPING OF THE SUTURE IT HAPPEN THREE TIME A ROW WITH DIFFERENT PATIENTS AND PROCEDURE. PRODUCT IS NOT FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24014177 ↗
• MalfunctionJan 5, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE KEEPS POPPING OFF THE SUTURE. THIS HAS HAPPENED MORE THAN ONCE FOR THIS SURGEON. NO ADVERSE IMPACT TO THE PATIENT/USER. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962280 ↗
• MalfunctionJan 5, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE KEEPS POPPING OFF THE SUTURE. THIS HAS HAPPENED MORE THAN ONCE FOR THIS SURGEON. NO ADVERSE IMPACT TO THE PATIENT/USER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962106 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE DEVICE BROKE. THE SALES REP STATED THAT DURING THE CLOSURE THE ACTUAL SUTURE BROKE. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837346 ↗
• MalfunctionDec 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A TOTAL HIP PROCEDURE, THE NEEDLE BROKE AWAY FROM THE SUTURE. THEY SWITCH TO A DIFFERENT LOT NUMBER AND IT WORKS. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802320 ↗
• MalfunctionDec 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN TOTAL HIP PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A TOTAL HIP PROCEDURE, THE NEEDLE BROKE AWAY FROM THE SUTURE. THEY SWITCH TO A DIFFERENT LOT NUMBER AND IT WORKS. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802317 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY SURGEON THAT THE NEEDLE KEPT PULLING OFF OF SUTURE STRAND WHEN PULLING THROUGH TISSUE WITHOUT ANY STRAIN ON THE NEEDLE. THIS HAPPENED WITH 3 STANDS IN THE SAME CASE. PA CONFIRMED THAT THIS IS WHAT HAPPENED - THAT IT HAPPENED WITH JUST DRIVING THROUGH AND THAT THEY DIDN'T REALLY PULL ON THE NEEDLE YET AT ALL. THEY BOTH SAID THIS HAPPENED IN A CASE LAST WEEK. A SURGICAL TECH SAID THE SAME THING HAPPENED WITH A DIFFERENT SURGEON LAST WEEK AS WELL. SUTURE CAME OUT WHOLE AND NOTHING LEFT BEHIND. THEY KEPT TRYING MORE SUTURES UNTIL THEY GOT ONE THAT WORKED. IT WAS IDENTIFIED ONE LIKELY LOT NUMBER FOR ALL OCCURRENCES. PROCEDURE WAS DELAYED BY 5 MINUTES. NO PATIENT HARM WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796382 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE NEEDLE IS KEEP POOPING OF THE SUTURE IT HAPPEN THREE TIME A ROW WITH DIFFERENT PATIENTS AND PROCEDURE. PRODUCT IS NOT FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796359 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE NEEDLE IS KEEP POOPING OF THE SUTURE IT HAPPEN THREE TIME A ROW WITH DIFFERENT PATIENTS AND PROCEDURE. PRODUCT IS NOT FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796356 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE NEEDLE IS KEEP POOPING OF THE SUTURE IT HAPPEN THREE TIME A ROW WITH DIFFERENT PATIENTS AND PROCEDURE. PRODUCT IS NOT FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796352 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY SURGEON THAT THE NEEDLE KEPT PULLING OFF OF SUTURE STRAND WHEN PULLING THROUGH TISSUE WITHOUT ANY STRAIN ON THE NEEDLE. THIS HAPPENED WITH 3 STANDS IN THE SAME CASE. PA CONFIRMED THAT THIS IS WHAT HAPPENED - THAT IT HAPPENED WITH JUST DRIVING THROUGH AND THAT THEY DIDN'T REALLY PULL ON THE NEEDLE YET AT ALL. THEY BOTH SAID THIS HAPPENED IN A CASE LAST WEEK. A SURGICAL TECH SAID THE SAME THING HAPPENED WITH A DIFFERENT SURGEON LAST WEEK AS WELL. SUTURE CAME OUT WHOLE AND NOTHING LEFT BEHIND. THEY KEPT TRYING MORE SUTURES UNTIL THEY GOT ONE THAT WORKED. IT WAS IDENTIFIED ONE LIKELY LOT NUMBER FOR ALL OCCURRENCES. PROCEDURE WAS DELAYED BY 5 MINUTES. NO PATIENT HARM WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795609 ↗
• MalfunctionDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY SURGEON THAT THE NEEDLE KEPT PULLING OFF OF SUTURE STRAND WHEN PULLING THROUGH TISSUE WITHOUT ANY STRAIN ON THE NEEDLE. THIS HAPPENED WITH 3 STANDS IN THE SAME CASE. PA CONFIRMED THAT THIS IS WHAT HAPPENED - THAT IT HAPPENED WITH JUST DRIVING THROUGH AND THAT THEY DIDN'T REALLY PULL ON THE NEEDLE YET AT ALL. THEY BOTH SAID THIS HAPPENED IN A CASE LAST WEEK. A SURGICAL TECH SAID THE SAME THING HAPPENED WITH A DIFFERENT SURGEON LAST WEEK AS WELL. SUTURE CAME OUT WHOLE AND NOTHING LEFT BEHIND. THEY KEPT TRYING MORE SUTURES UNTIL THEY GOT ONE THAT WORKED. IT WAS IDENTIFIED ONE LIKELY LOT NUMBER FOR ALL OCCURRENCES. PROCEDURE WAS DELAYED BY 5 MINUTES. NO PATIENT HARM WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795595 ↗
• MalfunctionJul 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, ACCORDING TO THE GYNECOLOGIC SURGEON, SHE PERFORMED A CESAREAN SECTION WITH A RESIDENT AND THEY USED THE SUTURE SXPP2B436 FOR UTERUS CLOSURE. DURING THE SUTURING PROCESS, WHILE THE RESIDENT SUTURED THE FIRST LAYER OF THE UTERUS AND MADE THE REVERSE SUTURING (BACKSTITCH), SHE PULLED THE SUTURE, THE NEEDLE DETACHED FROM THE SUTURE AND HER HAND SWUNG TOWARDS HER FACE (THE NEEDLE DID NOT TOUCH HER FACE). IN ORDER TO COMPLETE THE UTERUS CLOSURE ,SHE USED A VICRYL SUTURE AND COMPLETED THE UTERUS CLOSURE SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374023 ↗
• MalfunctionJul 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, ACCORDING TO THE GYNECOLOGIC SURGEON, SHE PERFORMED A CESAREAN SECTION WITH A RESIDENT AND THEY USED THE SUTURE (B)(6) FOR UTERUS CLOSURE. DURING THE SUTURING PROCESS, WHILE THE RESIDENT SUTURED THE FIRST LAYER OF THE UTERUS AND MADE THE REVERSE SUTURING (BACKSTITCH), SHE PULLED THE SUTURE, THE NEEDLE DETACHED FROM THE SUTURE AND HER HAND SWUNG TOWARDS HER FACE (THE NEEDLE DID NOT TOUCH HER FACE). IN ORDER TO COMPLETE THE UTERUS CLOSURE ,SHE USED A VICRYL SUTURE AND COMPLETED THE UTERUS CLOSURE SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373224 ↗
• MalfunctionJun 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN OPEN ABDOMEN/CHEST SURGERY FOR A CESAREAN SECTION, ONE OF THE NEEDLES WAS DETACHED FROM THE SUTURE AFTER THE NEEDLE PASSED THROUGH THE MIDDLE PART WITH THE 1ST STITCH. THE PRODUCT WAS USED ON THE MYOMETRIUM. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320497 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL PER THE SALES REP THAT THE SURGEON SAID THE NEEDLES POPPED OFF VERY EASILY WHILE USING PRODUCT. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943210 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SURGEON SAID THE NEEDLES POPPED OFF VERY EASILY DURING USE ON THE PATIENT. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942971 ↗
• MalfunctionMay 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SURGEON SAID THE NEEDLES POPPED OFF VERY EASILY DURING USE ON THE PATIENT. NO ADVERSE IMPACT PATIENT/USER. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942967 ↗