STRATAFIX SXPP2B403Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031464513), received between Dec 4, 2023 and Mar 18, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING AN UNKNOWN PROCEDURE THE STRATAFIX DEVICE, THE BARBS DID NOT APPEAR TO CUT DEEP ENOUGH AND WERE NOT ENGAGING THE TISSUE AS EXPECTED. THE HOSPITAL REPORTS THAT THEY USE STRATAFIX FREQUENTLY AND ARE FAMILIAR WITH ITS PERFORMANCE. WHILE SUTURING, THE BARBS WERE GRABBING INCONSISTENTLY. A SECOND DEVICE WAS OPENED, BUT STAFF NOTED THAT THE STRATAFIX ON THIS UNIT FELT DIFFERENT, AS IF THE BARBS WERE NOT FULLY FORMED OR WERE NOT ENGAGING PROPERLY. DEVICE IS RETURNING FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627961 ↗
• MalfunctionMar 17, 2026Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THE BARBED SUTURE DEVICE, THE BARBS DID NOT APPEAR TO CUT DEEP ENOUGH AND WERE NOT ENGAGING THE TISSUE AS EXPECTED. THE HOSPITAL REPORTS THAT THEY USE THE BARBED SUTURE FREQUENTLY AND ARE FAMILIAR WITH ITS PERFORMANCE. WHILE SUTURING, THE BARBS WERE GRABBING INCONSISTENTLY. A SECOND DEVICE WAS OPENED, BUT STAFF NOTED THAT THE BARBED SUTURE ON THIS UNIT FELT DIFFERENT, AS IF THE BARBS WERE NOT FULLY FORMED OR WERE NOT ENGAGING PROPERLY. DEVICE IS RETURNING FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617717 ↗
• MalfunctionMar 17, 2026Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE THE BARBED SUTURE DEVICE, THE BARBS DID NOT APPEAR TO CUT DEEP ENOUGH AND WERE NOT ENGAGING THE TISSUE AS EXPECTED. THE HOSPITAL REPORTS THAT THEY USE THE BARBED SUTURE FREQUENTLY AND ARE FAMILIAR WITH ITS PERFORMANCE. WHILE SUTURING, THE BARBS WERE GRABBING INCONSISTENTLY. A SECOND DEVICE WAS OPENED, BUT STAFF NOTED THAT THE BARBED SUTURE ON THIS UNIT FELT DIFFERENT, AS IF THE BARBS WERE NOT FULLY FORMED OR WERE NOT ENGAGING PROPERLY. DEVICE IS RETURNING FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617712 ↗
• MalfunctionNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SUTURE SNAPPED OFF FROM SWAGE AFTER TWO BITES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647454 ↗
• MalfunctionDec 4, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE IN 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT WHEN THE SURGEON WAS USING, IT FELT LIKE THE BARB WASN'T SNATCHING THE TISSUE ENTIRELY DURING A TOTAL KNEE REPLACEMENT. SUTURE ENDED UP SNAPPING AS HE TRIED TO PULL BUT HE WENT TO USE A VICRYL TY TO COMPLETE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263991 ↗