STRATAFIX SXPP1B412Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10705031236158), received between Apr 27, 2018 and May 22, 2026 — classified as 17 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT L5/S1 LUMBAR DISCECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT STARTED HAVING ISSUES WITH THE WOUND (B)(6) 2026. ON (B)(6) 2026, THE PATIENT HAD SOME SWELLING AT THE SURGICAL SITE WHEN PRESENTED TO A&E. ON (B)(6) 2026, WOUND DEHISCENCE AND SOME PUS NOTES, WOUND SWAB TAKEN AND PRESCRIBED ORAL ANTIBIOTICS. ON (B)(6) 2026, CLEAR STITCH POKING OUT AT THE SITE OF DEHISCENCE, THIS WAS REMOVED. PATIENT HAD SEVERAL WOUND CHECKS. FLAMINAL FORTE USED FOR WOUND MANAGEMENT. PATIENTS WOUND CLOSED THEN A FEW WEEKS AFTER OPENED UP AGAIN HAD MORE STITCHES COMING OUT WHICH WAS REMOVED AT URGENT CARE CENTRE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Purulent Discharge; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25256211 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT L1/2 LUMBAR DISCECTOMY AND UNDERCUTTING FACETECTOMY SPINAL CORD STIMULATOR PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PATIENT STARTED HAVING ISSUES WITH THE WOUND (B)(6) 2026. ON (B)(6) 2026 PATIENT REPORTED HAVING A SCAB CRANIAL ASPECT OF THE SURGICAL SITE WHICH WAS TENDER AT TOUCHING. THEN ON THE (B)(6) 2026 PUS DISCHARGING FROM THAT POINT AND SMALL GAPING (STICH ABSCESS?). (B)(6) 2026 STICH COULD BE FELT AT TIME OF DRESSING BUT NOT LOOSE ENOUGH OR ACCESSIBLE ENOUGH TO REMOVE. THE PATIENT HAD REGULAR WOUND CHECKS, FLAMINAL FORTE USED INITIALLY BUT THERE WAS NO IMPROVEMENT, THEN HONEY DRESSINGS. WOUND THEN FORMED A SCAB BUT SCAB CAME OFF AND STILL SMALL HOLE UNDERNEATH STILL NOT FULLY RESOLVED. PATIENT WAS PUT ON ORAL ANTIBIOTICS AS PROPHYLAXIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Purulent Discharge

  MAUDE report 25256208 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE BARBED SUTURE TORN OFF DURING DRAUGHT. THERE WERE NO SIGNIFICANT DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365609 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE BARBED SUTURE TORN OFF DURING DRAUGHT. THERE WERE NO SIGNIFICANT DELAYS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365607 ↗
• MalfunctionDec 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. CUSTOMER HAD THREE STRATAFIX SUTURES BREAK OFF AT THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906156 ↗
• MalfunctionDec 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. CUSTOMER HAD THREE STRATAFIX SUTURES BREAK OFF AT THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906155 ↗
• MalfunctionDec 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. CUSTOMER HAD THREE STRATAFIX SUTURES BREAK OFF AT THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906154 ↗
• MalfunctionDec 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. CUSTOMER HAD THREE STRATAFIX SUTURES BREAK OFF AT THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906151 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT, THE NEEDLE POOP FROM THE SUTURE. THERE WERE NO PATIENT ADVERSE EVENT. 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 23839148 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANNICULECTOMY ON AN UNKNOWN DATE IN 2025 AND BARBED SUTURE WAS USED. THE PATIENT HAD A DEHISCENCE AND INFECTION. STATED ONE WEEK POST OP PATIENT LOOKED GREAT. PATIENT THEN WENT TO ER BECAUSE OF PAIN AND HAD MILD PSEUDOMONAS CELLULITIS. SURGEON WILL DO WASH OUT AND CLOSE. SURGEON RECENTLY MOVED TO USING THE BARBED SUTURE AND IS NOT SURE IF THE ISSUE IS WITH THIS SUTURE OR SOMETHING ELSE. SURGEON USING LIQUIBAND RAPID OVER THE SKIN CLOSURE AND THEN COVERED WITH YELLOW MOIST GAUZE (MAY BE XEROFORM). ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Cellulitis; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 21756247 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANNICULECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT HAD A ¿BREAKDOWN¿ OF THEIR INCISION AND SURGEON HAD TO REOPERATE. SURGEON SAID HE DOESN¿T BELIEVE IT TO BE ANYTHING TO DO WITH THE CLOSING SUTURES BUT NOT SURE WHAT HAPPENED. PATIENT'S HUSBAND SAID THAT HE SPRAYED AN ¿ANTIBACTERIAL¿ SUBSTANCE ON PATIENT'S INCISION POST OP. SURGEON SAID IT COULD HAVE HAD SOMETHING TO DO WITH IT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21565172 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE WIRE BROKE DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381323 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE WIRE BROKE DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381322 ↗
• InjuryJan 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED ISSUES WITH NON-ABSORPTION OF THE SUTURE IN THE SUBCUTICULAR LAYER OF TISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 21241416 ↗
• InjuryJan 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED ISSUES WITH NON-ABSORPTION OF THE SUTURE IN THE SUBCUTICULAR LAYER OF TISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 21241412 ↗
• InjuryJan 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED ISSUES WITH NON-ABSORPTION OF THE SUTURE IN THE SUBCUTICULAR LAYER OF TISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 21241410 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025 AND BARBED SUTURE WAS USED. THE PATIENT WAS SEEN IN THE CLINIC WITH SPITTING SUTURE AND ARE RETURNED TO THE OPERATING ROOM TO HAVE THEIR INCISION RECLOSED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 21231360 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025 AND BARBED SUTURE WAS USED. THE PATIENT WAS SEEN IN THE CLINIC WITH SPITTING SUTURE AND ARE RETURNED TO THE OR TO HAVE THEIR INCISION RECLOSED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 21231359 ↗
• InjuryJan 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED ISSUES WITH NON-ABSORPTION OF THE SUTURE IN THE SUBCUTICULAR LAYER OF TISSUE. THE PATIENT WAS BROUGHT BACK TO THE OR FOR IRRIGATION AND DEBRIDEMENT OF THE INCISION SITE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21222699 ↗
• InjuryJan 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED ISSUES WITH NON-ABSORPTION OF THE SUTURE IN THE SUBCUTICULAR LAYER OF TISSUE. THE PATIENT WAS BROUGHT BACK TO THE OR FOR IRRIGATION AND DEBRIDEMENT OF THE INCISION SITE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 21222651 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON AN (B)(6) 2023 AND BARBED SUTURE WAS USED. PATIENT NOTIFIED PHYSICIAN ASSISTANT OF REDNESS AND WOUND DEHISCENCE ON PROXIMAL PART OF INCISION. THE REMAINING SUTURE WAS REMOVED FROM OPEN INCISION, STEROIDS' AND ANTIBIOTICS WERE GIVEN. NO REVISION SURGERY NEEDED. PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Skin Inflammation/ Irritation; Wound Dehiscence

  MAUDE report 18399528 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON AN UNKNOWN DATE IN 2023 AND BARBED SUTURE WAS USED. PATIENT NOTIFIED PHYSICIAN ASSISTANT OF RED RASH ON DISTAL PART OF INCISION AND WOUND DEHISCENCE AT PROXIMAL PART OF INCISION. THE REMAINING SUTURE WAS REMOVED FROM OPEN INCISION, STEROIDS' AND ANTIBIOTICS WERE GIVEN. NO REVISION SURGERY NEEDED. PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Rash; Wound Dehiscence

  MAUDE report 18398961 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED REDNESS AND WOUND DEHISCENCE ON THE PROXIMAL AND DISTAL PART OF INCISION. THE REMAINING SUTURE WAS REMOVED FROM THE OPEN WOUND, ANTIBIOTICS AND STEROIDS WERE PRESCRIBED, THERE WAS NO REVISION SURGERY DONE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Wound Dehiscence

  MAUDE report 18326458 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROSTHESIS ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. 5 TO 6 WEEKS AFTER THE PROCEDURE THE PATIENT EXPERIENCED LOCAL SKIN REACTION WITH SCAR DISUNITY AT DIFFERENT SITES OF THE SCARS AND EXPULSION OF THREAD FRAGMENTS. THE SUTURE WOULD BE AT THE ORIGIN OF THIS REACTION EVOKING AN INTOLERANCE. THE PATIENT GOT A REOPERATION. THIS CAUSED PAIN AND UNSIGHTLY SCARS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Pocket Erosion; Scar Tissue; Skin Inflammation/ Irritation; Wound Dehiscence

  MAUDE report 16291069 ↗
• MalfunctionOct 21, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ALIF PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15654259 ↗