STRATAFIX SXMP2B406Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031464377), received between Jun 16, 2025 and Sep 18, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084725 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084717 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084711 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084653 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 5 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084595 ↗
• MalfunctionSep 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MAMMOPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. NO FUNCTIONING BIDIRECTIONAL ANCHORS ON THE SUTURE SYSTEM. ANCHORS SLIGHTLY NOTICEABLE, BUT NO EFFECT WHEN THE SUTURE WAS USED. TWO PACKS WERE SECURED. THE SUTURE WAS USED ANYWAY. THERE WERE NO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084398 ↗
• MalfunctionSep 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MAMMOPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. NO FUNCTIONING BIDIRECTIONAL ANCHORS ON THE SUTURE SYSTEM. ANCHORS SLIGHTLY NOTICEABLE, BUT NO EFFECT WHEN THE SUTURE WAS USED. TWO PACKS WERE SECURED. THE SUTURE WAS USED ANYWAY. THERE WERE NO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084390 ↗
• MalfunctionSep 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MAMMOPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. NO FUNCTIONING BIDIRECTIONAL ANCHORS ON THE SUTURE SYSTEM. ANCHORS SLIGHTLY NOTICEABLE, BUT NO EFFECT WHEN THE SUTURE WAS USED. TWO PACKS WERE SECURED. THE SUTURE WAS USED ANYWAY. THERE WERE NO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084370 ↗
• MalfunctionSep 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MAMMOPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. NO FUNCTIONING BIDIRECTIONAL ANCHORS ON THE SUTURE SYSTEM. ANCHORS SLIGHTLY NOTICEABLE, BUT NO EFFECT WHEN THE SUTURE WAS USED. TWO PACKS WERE SECURED. THE SUTURE WAS USED ANYWAY. THERE WERE NO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084358 ↗
• MalfunctionSep 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MAMMOPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. NO FUNCTIONING BIDIRECTIONAL ANCHORS ON THE SUTURE SYSTEM. ANCHORS SLIGHTLY NOTICEABLE, BUT NO EFFECT WHEN THE SUTURE WAS USED. TWO PACKS WERE SECURED. THE SUTURE WAS USED ANYWAY. THERE WERE NO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084341 ↗
• MalfunctionSep 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MAMMOPLASTY PROCEDURE ON (B)(6)2025 AND BARBED SUTURE WAS USED. NO FUNCTIONING BIDIRECTIONAL ANCHORS ON THE SUTURE SYSTEM. ANCHORS SLIGHTLY NOTICEABLE, BUT NO EFFECT WHEN THE SUTURE WAS USED. TWO PACKS WERE SECURED. THE SUTURE WAS USED ANYWAY. THERE WERE NO PATIENT OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084230 ↗
• MalfunctionJun 16, 2025Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN MAY 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, (B)(6) DURING AN UNKNOWN PROCEDURE, THAT NEEDLES POPPING OFF AND NOT AS MANY BARBS ON SUTURE. UNKNOWN IF DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212004 ↗
• MalfunctionJun 16, 2025Material Separation; Defective Component; Material Separation; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN MAY 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM, #MW (B)(4) DURING AN UNKNOWN PROCEDURE, THAT NEEDLES POPPING OFF AND NOT AS MANY BARBS ON SUTURE. UNKNOWN IF DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212001 ↗

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