STRATAFIX SXPP1A429Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031245013), received between Mar 5, 2024 and Mar 5, 2024 — classified as 3 malfunctions.

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

• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE IN 2024, AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THREE NEEDLES POPPED OFF AT THE SWAGE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837386 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE IN 2024, AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THREE NEEDLES POPPED OFF AT THE SWAGE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837385 ↗
• MalfunctionMar 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE IN 2024, AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THREE NEEDLES POPPED OFF AT THE SWAGE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837384 ↗