STRATAFIX SXPP1A439Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031245310), received between Oct 8, 2020 and Jan 23, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED FOR FASCIAL CLOSURE. WOUND DEHISCENCE OCCURRED AFTER SURGERY. WHEN THE WOUND WAS REOPENED, THE PRODUCT WAS FOUND TO BE TORN ALONG ITS LENGTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24160775 ↗
• MalfunctionJul 15, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. YESTERDAY TWO OF THE 2-0 BARBED SUTURE BROKE OR FRAYED WHEN BEING USED IN A CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511719 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. YESTERDAY TWO OF THE 2-0 BARBED SUTURE BROKE OR FRAYED WHEN BEING USED IN A CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511621 ↗
• InjuryOct 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT WITH INFECTION UNDERWENT A TOTAL HIP REPLACEMENT ON UNKNOWN DATE AND THE BARBED SUTURE WAS USED IN THE SUBCUTANEOUS FAT LAYER. THE PATIENT CAME BACK WITH OOZING AND THE INCISION WAS REOPENED. THE BARBED SUTURE WAS ALMOST ABSORBED FULLY. FRAGMENTS WERE JUST LITTLE PIECES OF SUTURE THAT SURGEON WAS EASILY ABLE TO PULL OUT THEM. THE SURGEON OPINED THAT DUE TO THE PATIENT¿S INFECTION, A DEAD SPACE WAS CREATED IN THE DEEP TISSUE LAYERS AND HE DID NOT THINK THE SUTURES WERE THE CAUSE. THE PATIENT WAS RE-CLOSED WITH ANOTHER LIKE BARBED SUTURE. THERE WAS 5 WEEKS FROM THE TIME OF THE INITIAL SUTURE IMPLANTATION TO WHEN THE INCISION WAS REOPENED AND VERY BROKEN DOWN SUTURES WERE FOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Fluid Discharge; Necrosis; Not Applicable

  MAUDE report 10649947 ↗