STRATAFIX SXPP1B120Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031240865), received between Apr 13, 2023 and Jan 5, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGERY FOR BENIGN GYNECOLOGICAL DISEASE AND BARBED SUTURE WAS USED ON SUBCUTANEOUS DURING VERTICAL INCISION CASE/ LONGITUDINAL INCISIONAL LAPAROTOMY. CONTINUOUS BARBED SUTURES WERE PLACED FROM THE CEPHALAD SIDE, AND THE WOUND CLOSURE WAS COMPLETED BY BACKSTITCHING 2 STITCHES AT THE CAUDAL TRANSECTION. ATOFINE WAS USED FOR THE EPIDERMIS. ABOUT TWO MONTHS AFTER SURGERY, THE PATIENT CAME TO THE HOSPITAL WITH A SLIGHTLY OPEN WOUND IN THE BACKSTITCH AREA (CAUDAL SIDE). THE INCISIONAL WOUND FRAGMENT IN THE UPPER PUBIC BONE WAS SMALL AND OPEN, AND THE SUBCUTANEOUS AREA WAS KIND OF FLABBY AND SWOLLEN. A FEW MILLIMETERS OF NEARLY MELTED SPL WAS REMOVED FROM THE OPEN WOUND, AND THE SUBCUTANEOUS AREA LOOKED LIKE A PRESSURE ULCER. SULFADIAZINE SILVER WAS APPLIED. THE DERMATOLOGIST FOUND NO INFECTION, BUT RATHER AN INFLAMMATORY REACTION. HOWEVER, THE PATIENT'S ONE-MONTH POSTOPERATIVE CHECKUP SHOWED NO ABNORMAL FINDINGS. THE PATIENT WAS IN HER LATE 30S AND HAD NO BACKGROUND HISTORY OF OBESITY OR DIABETES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT IS RECOVERING WELL. THE WOUND WAS THEN FUSED IN ABOUT A WEEK. HEALING WAS COMPLETE. THE SUR

  Patient problems: Inflammation; Wound Dehiscence

  MAUDE report 18459732 ↗
• InjuryNov 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. ON (B)(6) 2023, THE PATIENT FELL DURING REHABILITATION AND THE WOUND OPENED BY ACCIDENT AND WAS RE-SUTURED. THE SURGEON SAID THIS WAS NOT A PRODUCT DEFECT. THE PATIENT IS IN THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 18163616 ↗
• MalfunctionApr 20, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON FELT THE BARB WAS WEAK DURING CONTINUOUS SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782172 ↗
• MalfunctionApr 13, 2023Positioning Failure; Defective Component; Positioning Failure; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE UNKNOWN CARDIOVASCULAR PROCEDURE, THE SURGEON FELT THE BARB WAS WEAK AND FELT MORE SLIPPERY THAN USUAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16736515 ↗
• MalfunctionApr 13, 2023Positioning Failure; Defective Component; Positioning Failure; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED ON SUBCUTANEOUS DERMIS USING A CONTINUOUS METHOD. THE SURGEON FELT THE PRODUCT WAS DIFFERENT THAN USUAL, THE BARB WAS WEAK, AND THE PRODUCT WAS CATCHING ON THE SKIN WEAKLY. THEREFORE, ANOTHER PACKAGE WAS OPENED. IT ALSO FELT SLIPPERY, BUT THE WOUND WAS CLOSED WITH THE PRODUCT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16736332 ↗