STRATAFIX SXMP2B401Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031464339), received between Jul 10, 2024 and May 6, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Break

  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 THE FA SAID THAT THE SUTURE BROKE 3 TIMES IN ONE TKA. THIS FA IS USED TO USING THE SINGLE ARMED STRATAFIX BUT IT IS ON BACKORDER SO SHE IS NOW USING THE DOUBLE ARMED. THE DEVICE WAS NOT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095278 ↗
• MalfunctionMay 6, 2026Break

  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 THE FA SAID THAT THE SUTURE BROKE 3 TIMES IN ONE TKA. THIS FA IS USED TO USING THE SINGLE ARMED STRATAFIX BUT IT IS ON BACKORDER SO SHE IS NOW USING THE DOUBLE ARMED. THE DEVICE WAS NOT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095273 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE IN (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE FA SAID THAT THE SUTURE BROKE 3 TIMES IN ONE TKA. THIS FA IS USED TO USING THE SINGLE ARMED STRATAFIX BUT IT IS ON BACKORDER SO SHE IS NOW USING THE DOUBLE ARMED. THE DEVICE WAS NOT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095271 ↗
• MalfunctionAug 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT PLASTIC SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THERE WAS AN ISSUE WITH THE RESISTANCE OF THE NEEDLE AND IT WAS NOT FUNCTIONING WELL DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22886250 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2025 AND BARBED SUTURE WAS USED ON THE HIGH SUBCUTIS. THE SURGEON WAS INSTRUCTED TO CLOSE WITHOUT INCRACUTAN LAYER. THEY WANT TO ALIGN ON A COMMON CLOSURE TECHNIQUE. THE PATIENT DEVELOPED A DISTAL DEHISCENCE WHEN TOPICAL SKIN ADHESIVE WAS REMOVED. DEHISCENCE OF WOUND - APPROX 3CM. THERE WAS THE NEED FOR ADDITIONAL TREATMENT OF THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22080924 ↗
• MalfunctionJul 10, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GENERAL SURGERY ON (B)(6) 2024 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED RIGHT THROUGH NOT STOPPING AT THE MID POINT OF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714048 ↗

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