DYONICS / INCISOR 7205558Recalls & reported problems
Smith & Nephew, Inc. · INCISOR CONCAVE CRV M.A.S.S. · Class 1
Data updated Oct 13, 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 03596010252579), received between May 9, 2017 and May 9, 2017 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2017Break
IT WAS REPORTED THE INCISOR CONCAVE CURVE DEVICE SHAFT BROKE. A BACK UP DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6555080 ↗
Other SAW, POWERED, AND ACCESSORIES devices
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- NA 72200616SSmith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES486 reports
- NA 72201500Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES136 reports
- PLATINUM 72205321Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES118 reports
- Zimmer Biomet™ 89-8509-450-60Zimmer Surgical SA · Saw, Powered, And Accessories83 reports
- NA 72200617Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES77 reports
- NA 72202530Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES53 reports
- DYONICS INCISOR 72203013Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES46 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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