DYONICS 7205357SRRecalls & reported problems
Smith & Nephew, Inc. · EP-1 MINI-MOTOR DRIVE, SUCTION LEVER, 10 FT 3 M CORD, SERVICE REPLACEMENT · 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 00885556582398), received between Nov 14, 2018 and Nov 14, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (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
- Overheating of Device1
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.
MalfunctionNov 14, 2018Overheating of Device
IT WAS REPORTED THAT THE DEVICE GENERATE HEATS DURING THE OPERATION. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8068719 ↗
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- Zimmer Biomet™ 89-8509-450-60Zimmer Surgical SA · Saw, Powered, And Accessories83 reports
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- 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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