STRATAFIX SXMP2B408Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031464315), received between Apr 24, 2023 and Apr 14, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT ARTHROPLASTY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE TOTAL JOINT ARTHROPLASTY, THE NEEDLES WERE PREMATURELY POPPING OFF. NO OTHER INFORMATION PROVIDED. NO PATIENT CONSEQUENCE. DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875196 ↗
• MalfunctionApr 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL JOINT ARTHROPLASTY ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE TOTAL JOINT ARTHROPLASTY, THE NEEDLES WERE PREMATURELY POPPING OFF. NO OTHER INFORMATION PROVIDED. NO PATIENT CONSEQUENCE. DEVICE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875192 ↗
• MalfunctionApr 3, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT WHILE THE SURGEON'S WERE CLOSING, THE BARBED SUTURE DOUBLE ARMED STARTED TO FRAY. THE SUTURE STARTED TO FRAY ON THE WORKING SIDE AFTER A FEW PASSES THROUGH THE TISSUE WHICH LED TO MORE BARBED SUTURES BEING OPENED AND THE SAME PROBLEM OCCURRING. AFTER SEVERAL SUTURE PACKS, THE INCISION WAS CLOSED. THE DEVICE WAS NOT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776743 ↗
• MalfunctionApr 3, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT WHILE THE SURGEON'S WERE CLOSING, THE BARBED SUTURE DOUBLE ARMED STARTED TO FRAY. THE SUTURE STARTED TO FRAY ON THE WORKING SIDE AFTER A FEW PASSES THROUGH THE TISSUE WHICH LED TO MORE BARBED SUTURES BEING OPENED AND THE SAME PROBLEM OCCURRING. AFTER SEVERAL SUTURE PACKS, THE INCISION WAS CLOSED. THE DEVICE WAS NOT RETURNING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776742 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE THREAD TORN WHEN STITCHING BACK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162334 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN CLOSURE PROCEDURE IN (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, PER USER FACILITY MEDWATCH FORM (B)(4); SUTURE FRAYED AND BROKE DURING SKIN CLOSURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21039516 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING A TOTAL KNEE REPLACEMENT PROCEDURE THAT THE SUTURE BROKE WHILE CLOSING THE SKIN. ANOTHER SUTURE WAS USED TO CONTINUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853232 ↗
• MalfunctionDec 4, 2024

  SUTURE FRAYED AND BROKE DURING SKIN CLOSURE. STRATAFIX¿ SPIRAL MONOCRYL® PLUS SUTURE. REF: SXMP2B408, LOT: UCBBZL, GTIN: (B)(4). EXP: 02-28-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20841923 ↗
• MalfunctionApr 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS POPPING OFF THE SUTURE WHEN THE SURGEON WAS TRYING TO CLOSE THE INCISION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19107013 ↗
• MalfunctionApr 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS POPPING OFF THE SUTURE WHEN THE SURGEON WAS TRYING TO CLOSE THE INCISION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19107012 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES CONSULTANT PER CUSTOMER THAT SUTURE KEEPS BREAKING. UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES. 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 18722746 ↗
• MalfunctionSep 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHEN USING ONE BARBED SUTURE IT SUDDENLY SNAPPED IN THE MIDDLE. A SECOND PIECE WAS OPENED TO CONTINUE THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17828000 ↗
• MalfunctionApr 24, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, A FEW PASSES AND THEN NEEDLE DETACHED FROM SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16802850 ↗

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