STRATAFIX SXMP2B414Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031464360), received between Feb 4, 2025 and Jun 22, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT REQUIRED A REVISION. THE PATIENT EXPERIENCED A SUPERFICIAL DEHISCENCE OF ABOUT 0.5-1 CM. THE DOCTOR HAD TO REMOVE SUTURE AND THEN USE A TOPICAL SKIN ADHESIVE AND THE PATIENT HEALED FINE AFTER THAT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 25579291 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT REQUIRED A REVISION. THE PATIENT EXPERIENCED A SUPERFICIAL DEHISCENCE OF ABOUT 0.5-1 CM. THE DOCTOR HAD TO REMOVE SUTURE AND THEN USE A TOPICAL SKIN ADHESIVE AND THE PATIENT HEALED FINE AFTER THAT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 25579284 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT REQUIRED A REVISION. THE PATIENT EXPERIENCED A SUPERFICIAL DEHISCENCE OF ABOUT 0.5-1 CM. THE DOCTOR HAD TO REMOVE SUTURE AND THEN USE A TOPICAL SKIN ADHESIVE AND THE PATIENT HEALED FINE AFTER THAT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 25579278 ↗
• MalfunctionMay 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP, ONCE CLOSING SUBCUTICULAR LAYER AFTER A FEW PASSES THE NEEDLE POPPED OFF THE SUTURE. PRODUCT PACKAGING AVAILABLE FOR RETURN. WE HAVE HAD MULTIPLE REPORTS OF COMPLAINTS FROM THIS PARTICULAR CODE NOW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172301 ↗
• MalfunctionMay 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP, ONCE CLOSING SUBCUTICULAR LAYER AFTER A FEW PASSES THE NEEDLE POPPED OFF THE SUTURE. PRODUCT PACKAGING AVAILABLE FOR RETURN. WE HAVE HAD MULTIPLE REPORTS OF COMPLAINTS FROM THIS PARTICULAR CODE NOW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172240 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP DURING TOTAL KNEE ARTHROPLASTY PROCEDURE, ONCE CLOSING SUBCUTICULAR LAYER AFTER A FEW PASSES THE NEEDLE POPPED OFF THE SUTURE. PRODUCT PACKAGING AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164893 ↗
• MalfunctionMay 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THEY RECEIVED COMPLAINT ABOUT STRATAFIX SPIRAL MONOCRYL PRODUCT CODE SXMP2B414. 2 COMPLAINTS FROM THE SAME LOT. FIRST ONE THE SUTURE POPPED OFF THE NEEDLE AND SECOND COMPLAINT THE THREAD BROKE WHEN THEY FLEXED THE KNEE. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25100728 ↗
• MalfunctionJun 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING SUBCUTICULAR CLOSURE ON AN ORTHOPEDIC PROCEDURE THAT THE NEEDLE POPPED OFF OF A SUTURE. ANOTHER STITCH WAS OPENED AND CLOSURE WAS COMPLETED WITH THAT. NO PATIENT CONSEQUENCE NOTED. THE DEVICE WAS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203727 ↗
• MalfunctionJun 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE TOPPED OFF THE SUTURE. NO PATIENT HARMED. UNKNOWN HOW THE CASE WAS COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125499 ↗
• MalfunctionFeb 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN A TOTAL HIP REPLACEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A TOTAL HIP, THE SCRUB TECH HAD THE SUTURE LOADED ON TWO DIFFERENT NEEDLE HOLDERS, THE SUTURE HAD POPPED OFF. THE SURGEON NOTED THIS HAS HAPPENED A COUPLE OF TIMES WHERE THE SUTURE IS POPPED OFF. CASE WAS COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303630 ↗
• MalfunctionFeb 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN A TOTAL HIP REPLACEMENT ON (B)(6)2025 AND SUTURE WAS USED. DURING A TOTAL HIP, THE SCRUB TECH HAD THE SUTURE LOADED ON TWO DIFFERENT NEEDLE HOLDERS, THE SUTURE HAD POPPED OFF. THE SURGEON NOTED THIS HAS HAPPENED A COUPLE OF TIMES WHERE THE SUTURE IS POPPED OFF. CASE WAS COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303626 ↗

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