STRATAFIX SXPP1B430Recalls & reported problems
Ethicon, LLC · Knotless Tissue Control Device, Violet Unidirectional (Antibacterial) Synthetic Absorbable Device · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031235823), received between Dec 12, 2019 and Apr 2, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Aug 13, 2019Terminated
The product does not meet certain internal strength testing specifications.
Z-0047-2020 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Break2
- Positioning Failure1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE SUTURE WAS USED. DURING UTERINE SUTURE, THE THREAD BECAME ANCHORED IN THE TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24764765 ↗MalfunctionDec 29, 2021Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING SUTURING ON THE MYOMETRIUM. BEFORE THE SUTURE WAS BROKEN, HEMOSTASIS WAS PERFORMED USING A BIPOLAR. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13111612 ↗MalfunctionDec 12, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING THE PROCEDURE. THERE WERE NO CONSEQUENCES FOR THE PATIENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9461332 ↗
Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices
- STRATAFIX SXPP1A405Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE617 reports
- STRATAFIX SXPP1A400Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE485 reports
- STRATAFIX SXPP1A401Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE446 reports
- STRATAFIX SXPP1A301Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE443 reports
- STRATAFIX SXPP2B405Ethicon, LLC · Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A406Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE339 reports
- STRATAFIX SXPP1A404Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
- STRATAFIX SXPP1B420Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death229 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.