STRATAFIX SXMP2B405Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10705031464346), received between Apr 17, 2024 and Apr 29, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM QUILL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928726 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM QUILL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928698 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM QUILL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928694 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM QUILL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928582 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM QUILL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928579 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM QUILL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928433 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM QUILL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928421 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM QUILL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928393 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM QUILL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928375 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM QUILL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928358 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM (B)(6). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928356 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLES POPPING-OFF WHILE USING THE SUTURE, MD SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. HE SAID PRIOR TO THE PACKAGE CHANGE OF THE BIDIRECTIONAL NEEDLES, HE DID NOT HAVE ANY ISSUES AND HAS USED THE BIDIRECTIONAL SPIRAL SINCE BEFORE ETHICON PURCHASED FROM QUILL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928347 ↗
• MalfunctionApr 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE NEEDLES POPPING-OFF WHILE USING BARBED SUTURE. THE DOCTOR SHARED THAT IT HAS NOT BEEN AN ISOLATED INCIDENT AND HE HAS HAD IT HAPPEN MULTIPLE TIMES OVER THE LAST 6 MONTHS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921290 ↗
• MalfunctionApr 17, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBS ON THE SUTURE DID NOT CATCH WHILE SUTURING AND WOULD KEEP FALLING THROUGH. THEY GOT A SECOND TO PROCEED BUT IT DID THE SAME THING MAKING IT SLIP ALL THE WAY OUT WHEN PULLING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127662 ↗
• MalfunctionApr 17, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBS ON THE SUTURE DID NOT CATCH WHILE SUTURING AND WOULD KEEP FALLING THROUGH. THEY GOT A SECOND TO PROCEED BUT IT DID THE SAME THING MAKING IT SLIP ALL THE WAY OUT WHEN PULLING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127659 ↗

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