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STRATAFIX SXPP1B425Recalls & reported problems

Ethicon, LLC · Knotless Tissue Control Device, Violet Unidirectional (Antibacterial) Synthetic Absorbable Device · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031236189), received between Jun 8, 2023 and Jun 8, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionJun 8, 2023Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE TWICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17087915 ↗
  • MalfunctionJun 8, 2023Break; Break

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE TWICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17087910 ↗

Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices

All SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.