STRATAFIX SXMP1B438Recalls & reported problems
Ethicon, LLC · Knotless Tissue Control Device, Undyed Unidirectional (Antibacterial) Synthetic Absorbable Device · Class 2 · Implant
All models of STRATAFIX (181)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031246515), received between Feb 6, 2025 and Oct 21, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Separation1
Patient problems
- Local Reaction1
- No Clinical Signs, Symptoms or Conditions1
- Pocket Erosion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. 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 23349735 ↗InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITHIN THE LAST 18 MONTHS AND A BARBED SUTURE WAS USED. POST-OP, THE PRODUCT WAS SPITTING. THE PATIENT RETURNED WITH PROBLEMS. THE DRESSING WAS CHANGED AND THE PATIENT CONTINUED TO RETURN. THE DOCTOR IS NOT SURE WHAT THE ISSUE WAS. IT HAS BEEN NARROWED DOWN TO ISSUES WITH THE BARBED SUTURE. THE SKIN SPITTING OUT, THE BAR IN THE WOUND WHERE THE REACTION IS OCCURRING. THE DOCTOR TRIED RUBBING IT, AND TEN DAYS TO TWO WEEKS LATER, IT DISSOLVED. WITHIN TWO TO THREE WEEKS, THE PATIENT WAS UNCOMFORTABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Local Reaction; Pocket Erosion
MAUDE report 21323623 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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