STRATAFIX SXMP1B419Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031236394), received between Aug 13, 2025 and Dec 11, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778079 ↗
• MalfunctionAug 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A BOX OF THE SUTURE WITH A FEW LEFTS IN IT. IT WAS REPORTED THAT THEY WERE HAVING ISSUES WITH THE NEEDLE POPPING OFF THE SUTURE, LIKE A POP-OFF. THEY OPENED A NEW BOX WITH A DIFFERENT LOT NUMBER, AND IT WORKED FINE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793280 ↗
• MalfunctionAug 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A BOX OF THE SUTURE WITH A FEW LEFT IN IT. IT WAS REPORTED THAT THEY WERE HAVING ISSUES WITH THE NEEDLE POPPING OFF THE SUTURE, LIKE A POP-OFF. THEY OPENED A NEW BOX WITH A DIFFERENT LOT NUMBER, AND IT WORKED FINE. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793247 ↗