ENDOBUTTON 7207323Recalls & reported problems
Smith & Nephew, Inc. · ENDOBUTTON CL FIXATION BUTTON WITH 20 MM CONTINUOUS LOOP SUTURE · Class 2 · Implant
All models of ENDOBUTTON (21)
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 03596010388278), received between Jun 12, 2018 and May 8, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2019Break
IT WAS REPORTED THAT DURING THE SURGERY THE LOOP WAS BROKEN. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. DELAY GREATER THAN 30 MINUTES WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8593063 ↗MalfunctionJun 12, 2018Break
IT WAS REPORTED THAT THE TENDON BROKE WHEN IT WAS BEING PULLED INTO THE FEMORAL TUNNEL WITH A HERNIA PLATE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7593996 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
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- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
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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