STRATAFIX SXMP2B410Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031464322), received between Jun 11, 2024 and Mar 31, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON AN UNKNOWN DATE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE PULLED THROUGH THE TISSUE AND BARBS DID NOT ENGAGE EVEN THOUGH THEY HAD ALREADY DONE SEVERAL PASSES. SURGICAL DELAY UNKNOWN. PATIENT CONSEQUENCES UNKNOWN. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732261 ↗
• MalfunctionMar 31, 2025Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON AN UNKNOWN DATE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE PULLED THROUGH THE TISSUE AND BARBS DID NOT ENGAGE EVEN THOUGH THEY HAD ALREADY DONE SEVERAL PASSES. SURGICAL DELAY UNKNOWN. PATIENT CONSEQUENCES UNKNOWN. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732245 ↗
• MalfunctionMar 19, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING AN ABDOMINOPLASTY, USING BIDIRECTIONAL BARBED SUTURE THE DOCTOR NOTED THAT THE SUTURE BARBS WERE NOT DEPLOYING ON BOTH THE TYPES OF BARBED SUTURES. THE DOCTOR WAS DOING DIFFERENT TECHNIQUES. THE BARBS WERE NOT DEPLOYING WITH MULTIPLE PASSES. MULTIPLE SUTURES WERE ATTEMPTED. CASE WAS COMPLETED BY PULLING MORE SUTURES FROM THE SAME BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642396 ↗
• MalfunctionJun 11, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL JOINT REPLACEMENT PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURE STRAND BROKE DURING CLOSURE. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE, AND THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509725 ↗

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