STRATAFIX SXPP2B414Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031464612), received between Dec 19, 2025 and Apr 14, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Component Misassembled

  IT WAS REPORTED UPON OPENING THE BOX OF BARBED SUTURE ON (B)(6) 2026. THE LABEL OF THE OUTER BOX SHOWN AS PRODUCT CODE WITH CUTTING NEEDLE BUT INNER SUTURES ARE PRODUCT WITH ROUNDED BODY. FOUND ONLY 1 PIECE WITH THE CORRECT ITEM OUT OF WHOLE BOX. NO REPORTED ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877570 ↗
• MalfunctionDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURE BROKE FROM NEEDLE OCCURRED DURING OPERATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849524 ↗