STRATAFIX SXMP1B115Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031236769), received between Sep 4, 2019 and Oct 17, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT NEEDLE BROKE OFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323797 ↗MalfunctionSep 4, 2019Positioning Problem; Positioning Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE BARBED SUTURE PRODUCT IS MORE LIKE A BUMP AND LESS LIKE A BARB. IT DOES NOT CLOSE TISSUE OR SLIDE THROUGH WELL BECAUSE OF ITS DESIGN. THERE WERE NO BAD OUTCOMES AS A RESULT OF THIS TRIAL WITH BARBED SUTURES. IT WAS STOPPED ABRUPTLY BECAUSE IT HAD POTENTIAL FOR HARMFUL COMPLICATIONS TO OUR PATIENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8963246 ↗
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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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