Formula 0375701500Recalls & reported problems
Stryker Corporation · Shaver Handpiece, No Buttons · Class 1
All models of Formula (43)
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 07613327057621), received between Aug 14, 2024 and Aug 14, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT A SHAVER HANDPIECE HAD OVERHEATED A FEW WEEKS PRIOR WHICH APPARENTLY RESULTED IN A BURN TO THE PATIENT¿S SKIN. THE ONLY TREATMENT PROVIDED WAS A REDRESSING OF THE SURGICAL WOUND. IT WAS DESCRIBED AS A 2ND DEGREE AND DOCUMENTED THAT THE WOUND WAS HEALING APPROPRIATELY.
Patient problems: Burn(s)
MAUDE report 19987144 ↗
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- NA 0277096325Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL95 reports
- NA 310.25Synthes GmbH · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL91 reports
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- NA 0277096275Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL72 reports
- Arthrex® AR-7300DSArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL70 reports
- NA 0277096277Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL69 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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