STRATAFIX SXMP2B407Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031464384), received between May 26, 2022 and Jul 31, 2026 — classified as 1 injury, 4 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K192580); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098074 ↗
• MalfunctionMay 13, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VIDEO-ASSISTED THORACOSCOPIC SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY, WHEN THE SURGEON WAS CLOSING, THE SUTURE WAS GLIDED THROUGH THE SKIN AND THE SUTURE BARBS WERE NOT THERE. THERE WAS ONLY A DELAY OF 1 MINUTE IN THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163032 ↗
• MalfunctionDec 15, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND BARBED SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED TO THE SALES REP THAT THE FACILITY ORDERED A BOX OF 4¿0 SUTURE. WHEN THEY OPENED THE BOX IT INCLUDED SOME 3¿0 SUTURE AS WELL AS 4-0 SUTURE. EIGHT DEVICES WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336975 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GENERAL PLASTIC COMBO PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IN THE MIDDLE OF SUTURING THE NEEDLE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632392 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT CAME BACK FIVE DAYS LATER TO REPORT WHAT THEY THOUGHT WAS A WORM TRAVELING IN THEIR BODY FROM THEIR SHOULDER TO UPPER BACK TO LOWER BACK. THE PATIENT THEN WENT TO A DIFFERENT HOSPITAL, AND A DOCTOR REMOVED WHAT LOOKED LIKED THE DEVICE. IT WAS CONFIRMED THAT IT WAS A PIECE OF BARBED SUTURE THAT WAS REMOVED AND NOT A WORM. THE PROCEDURE WAS COMPLETED. THE PATIENT RECEIVED ANTIBIOTICS. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS FINE, AND THE HEALING FROM THE SURGERY WHICH WENT WELL.

  Patient problems: Pocket Erosion

  MAUDE report 14517681 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192580. One submission often covers many models, so check the product and lot details in each record.

• Z-1533-2024 · Mar 8, 2024 · Open, Classified
  STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft