Dermatome
FDA adverse event reports and recall history for dermatome (product code GFD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 8,048
- Deaths
- 1
- Injuries
- 1,595
- Malfunctions
- 6,359
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-12-15Open, ClassifiedProcess control
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
The devices may have a misaligned thickness control bar.
- 2025-12-15Open, ClassifiedProcess control
Zimmer Dermatome AN, Model/Catalog Number: 88710100
The devices may have a misaligned thickness control bar.
- 2023-10-06Open, ClassifiedProcess control
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010
Skin 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 harvests to adequately cover the area
- 2020-09-12TerminatedMixed-up of materials/components
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
- 2020-09-12TerminatedMixed-up of materials/components
Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
- 2020-09-12TerminatedMixed-up of materials/components
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
- 2016-11-05TerminatedProcess design
Zimmer Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.
Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after usage over time (see Image 1). There have been no injuries associated with the reported complaints. In addition, an independent assessment determined that the blistering, peeling and potentially flaking of the surface coating is not expected to result in any long range health consequences. Given that the frequency of this surface coating condition can worsen with age, Zimmer Biomet Surgical is currently making preparations for replacement activities to follow in order to prevent future complaints. This document is provided to alert all users of the potential for the surface coating to exhibit blistering, peeling, and discoloring after usage over time. A separate recall removal notice will be issued to facilities, in phases, with detailed instructions beginning in August 2016. Your sales representatives will be notified when a replacement is ready. Do not return product at this time as part of this action. Image 1.
- 2016-08-04TerminatedProcess design
Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
- 2016-08-04TerminatedProcess design
Zimmer Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
- 2016-08-04TerminatedProcess design
Zimmer Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
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