STRATAFIX SXPP1B411Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10705031236141), received between Mar 5, 2019 and Sep 30, 2026 — classified as 25 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 37 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50947350 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50947333 ↗
• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923737 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANNICULECTOMY PROCEDURE ON (B)(6) 2026 DUE TO EXCESSIVE PANNICULUS AND INTERTRIGO CANDIDIASIS AND BARBED SUTURE WAS USED ON THE FAT AND SKIN. POST-OP, THE PATIENT EXPERIENCED A SUBCLINICAL HEMATOMA. THE PATIENT WENT HOME POST OP DAY 1, REMOVED DRAIN, SKIN DIED FOLLOWING WEEK. THE SKIN DIED, ON POST OP DAY 10 THE PATIENT CAME TO ER AND UNDERWENT WOUND DEBRIDEMENT. THE SUTURE BEGAN BREAKING DOWN DURING THE SECOND PROCEDURE. THE PATIENT HAS RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Necrosis

  MAUDE report 24400378 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANNICULECTOMY PROCEDURE ON (B)(6) 2026 DUE TO INTERTRIGO CANDIDIASIS AND BARBED SUTURE WAS USED ON THE FAT. POST-OP, THE PATIENT EXPERIENCED A HEMATOMA/HEMORRHAGE. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION ON POST OP DAY 1 AND DEVELOPED RAPID RESPONSE HYPERTENSION AND WAS TRANSFERRED TO STEP DOWN. THE PATIENT HAS RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension

  MAUDE report 24400368 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. AT 2-3 MONTHS POST-OP, THE PATIENT EXPERIENCED IRRITATION, SMALL ABSCESS, REDNESS AND INFECTION FOLLOWING SUTURE TRACK MARKS. THE REDNESS FOLLOWS THE SUTURE BITE TRACK AND THE SURGEON QUESTIONED IF IT IS A PATIENT ALLERGY OR SOMETHING ELSE. THE SURGEON HAS GONE BACK TO USING A DIFFERENT SUTURE TO CLOSE THE SUBCUTANEOUS LAYER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Erythema; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22341256 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. AT 2-3 MONTHS POST-OP, THE PATIENT EXPERIENCED IRRITATION, SMALL ABSCESS, REDNESS AND INFECTION FOLLOWING SUTURE TRACK MARKS. THE REDNESS FOLLOWS THE SUTURE BITE TRACK AND THE SURGEON QUESTIONED IF IT IS A PATIENT ALLERGY OR SOMETHING ELSE. THE SURGEON HAS GONE BACK TO USING A DIFFERENT SUTURE TO CLOSE THE SUBCUTANEOUS LAYER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Erythema; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22341254 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. AT 2-3 MONTHS POST-OP, THE PATIENT EXPERIENCED IRRITATION, SMALL ABSCESS, REDNESS AND INFECTION FOLLOWING SUTURE TRACK MARKS. THE REDNESS FOLLOWS THE SUTURE BITE TRACK AND THE SURGEON QUESTIONED IF IT IS A PATIENT ALLERGY OR SOMETHING ELSE. THE SURGEON HAS GONE BACK TO USING A DIFFERENT SUTURE TO CLOSE THE SUBCUTANEOUS LAYER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Erythema; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22341253 ↗
• InjuryJun 26, 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 AND A BARBED SUTURE WAS USED. AT 2-3 MONTHS POST-OP, THE PATIENT EXPERIENCED IRRITATION, SMALL ABSCESS, REDNESS AND INFECTION FOLLOWING SUTURE TRACK MARKS. THE REDNESS FOLLOWS THE SUTURE BITE TRACK AND THE SURGEON QUESTIONED IF IT IS A PATIENT ALLERGY OR SOMETHING ELSE. THE SURGEON HAS GONE BACK TO USING A DIFFERENT SUTURE TO CLOSE THE SUBCUTANEOUS LAYER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Erythema; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 22341252 ↗
• MalfunctionJun 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON WENT TO USE THE SUTURE THE THREAD DETACHED FROM THE NEEDLE. HAD TO OPEN ANOTHER SUTURE TO COMPLETE CLOSURE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127875 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. "THE SUTURE CONTINUED TO BREAK WHEN THE SURGEON WAS TRYING A TIE A KNOT. HAD TO OPEN ANOTHER PACKAGE." THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741280 ↗
• InjuryJan 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIP SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN ISSUE WITH NON-ABSORPTION OF THE SUTURE IN THE SUBCUTICULAR LAYER OF TISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 21241729 ↗
• InjuryJan 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIP SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN ISSUE WITH NON-ABSORPTION OF THE SUTURE IN THE SUBCUTICULAR LAYER OF TISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 21241727 ↗
• InjuryJan 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIP SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN ISSUE WITH NON-ABSORPTION OF THE SUTURE IN THE SUBCUTICULAR LAYER OF TISSUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 21241726 ↗
• 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 OPERATING ROOM FOR IRRIGATION AND DEBRIDEMENT OF THE INCISION SITE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 21222739 ↗
• 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 21222648 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20711982 ↗
• InjuryNov 20, 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 PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON RECENTLY SWITCHED TO CLOSING ALL HIS TOTAL HIPS WITH THE BARBED SUTURE. THE SURGEON REPORTED THAT HE HAD TO DISCONTINUE USE BECAUSE A PATIENT HAD ¿PUS OUT¿. THE PATIENT WAS TREATED AND THEY ARE FINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Purulent Discharge

  MAUDE report 18179275 ↗
• InjuryNov 20, 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 PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON RECENTLY SWITCHED TO CLOSING ALL HIS TOTAL HIPS WITH THE BARBED SUTURE. THE SURGEON REPORTED THAT HE HAD TO DISCONTINUE USE BECAUSE A PATIENT HAD ¿PUS OUT¿. THE PATIENT WAS TREATED AND THEY ARE FINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Purulent Discharge

  MAUDE report 18179274 ↗
• InjuryNov 20, 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 PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON RECENTLY SWITCHED TO CLOSING ALL HIS TOTAL HIPS WITH THE BARBED SUTURE. THE SURGEON REPORTED THAT HE HAD TO DISCONTINUE USE BECAUSE A PATIENT HAD ¿PUS OUT¿. THE PATIENT WAS TREATED AND THEY ARE FINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Purulent Discharge

  MAUDE report 18179273 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN PROCEDURE ON A KNEE PROSTHESES AND A BARBED SUTURE WAS USED. POST-OP, 5 DAYS AFTER SURGERY, IT BEGINS TO DRAIN FLUID FROM THE WOUND (WHICH IS NORMAL), BUT IN THIS CASE A LOT OF FLUID AND TISSUE HAS COME OUT, IT SEEMED INFECTED. A FEW WEEKS AGO A BLUE LIQUID CAME OUT. THE PATIENT DID NOT REQUIRE A REVISION SURGERY OR REMOVAL OF HARDWARE, HOWEVER, IT REQUIRED DRAINING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Hypersensitivity/Allergic reaction; Inflammation; Purulent Discharge; Unspecified Infection

  MAUDE report 17606913 ↗
• MalfunctionDec 28, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE THREAD HAS COME LOOSE FROM THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16063275 ↗
• MalfunctionDec 20, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING A UTERUS CLOSURE, THE SUTURE BROKE OFF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019654 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A SPINAL FUSION ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE CUSTOMER WAS USING A SUTURE AND IT SNAPPED. ON THE THIRD PASS OF THE SUTURE BROKE. THEY CUT OUT THE SUTURE. CASE COMPLETED WITH ANOTHER TYPE OF SUTURE. DEVICE IS NOT AVAILABLE FOR RETURN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949706 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROSCOPY ON (B)(6) 2021 AND A BARBED SUTURE WAS USED. ON (B)(6) 2021, THE PATIENT CALLED THE OFFICE OF THE PROVIDER WITH CONCERNS ABOUT THEIR INCISION. ON (B)(6) 2021, THE PATIENT WAS SEEN IN THE CLINIC AND HAD WOUND DEHISCENCE AT THE PROXIMAL AND DISTAL ENDS OF THE INCISION. THE PATIENT POSSIBLY EXPERIENCED LOCAL REDNESS AND PUS. THE PATIENT WAS INSTRUCTED TO APPLY BETADINE TWICE A DAY. ON (B)(6) 2022, THE PATIENT WAS SEEN IN THE OFFICE AND IT WAS DETERMINED THAT IRRIGATION AND DEBRIDEMENT WAS NOT NECESSARY. THE SUTURE TAILS WERE REMOVED IN THE AREAS OF DEHISCENCE. THE INCISION IS CURRENTLY HEALING WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Purulent Discharge; Skin Inflammation/ Irritation; Wound Dehiscence

  MAUDE report 13423839 ↗