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Dermatome

FDA product code GFD · Class 1 · General, Plastic Surgery

223
Registered devices
8,121
Adverse events
22
Recalls
12
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-11-24Zimmer Surgical IncThe devices may have a misaligned thickness control bar.
2025-11-24Zimmer Surgical IncThe devices may have a misaligned thickness control bar.
2023-09-05Zimmer Surgical IncSkin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harv
2020-08-04Integra LifeSciences Corp.lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
2020-08-04Integra LifeSciences Corp.lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
2020-08-04Integra LifeSciences Corp.lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
2018-06-08Zimmer Surgical IncDevices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that
2018-04-17Exsurco MedicalImproper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.
2016-07-04Zimmer Surgical IncZimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usa
2016-07-04Zimmer Surgical IncThe surface coating applied to the device is blistering, peeling and discoloring after usage over time

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.