NA 7205341Recalls & reported problems
Smith & Nephew, Inc. · 4.5 MM LONG FULL RADIUS SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE · 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 03596010251664), received between Jan 12, 2018 and Jan 12, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Metal Shedding Debris” (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
- Metal Shedding Debris1
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.
MalfunctionJan 12, 2018Metal Shedding Debris
IT WAS REPORTED THAT UPON USE THE PRODUCT LEFT METAL SHAVINGS IN THE JOINT OF THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7187916 ↗
Other SAW, POWERED, AND ACCESSORIES devices
- DYONICS POWERMAX ELITE 72200616Smith & Nephew, Inc. · SAW, POWERED, AND ACCESSORIES4,290 reports
- 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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