ETHIBOND; DURAKNOT SW112Recalls & reported problems
Ethicon Endo-Surgery, LLC · Endosuture System Reload Units for Suture Assistant With Ethibond EXCEL Green Braided Polyester Suture · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705036002901), received between Mar 9, 2018 and Mar 9, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2018Device Operates Differently Than Expected
SURGEON COULD NOT ARM THIS PARTICULAR RELOAD FROM CASSETTE INTO THE SUTURE ASSISTANT DEVICE. NO PATIENT CONSEQUENCES. NO DELAY IN SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7328415 ↗
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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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