Dermatome

Zimmer Air Dermatome, Model/Catalog Number: 00880100100

The devices may have a misaligned thickness control bar.

Zimmer Dermatome AN, Model/Catalog Number: 88710100

The devices may have a misaligned thickness control bar.

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

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

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 ski

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

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 instru

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

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. The

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

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 t

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.

Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00.

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Zimmer Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01.

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Zimmer Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 .

The surface coating applied to the device is blistering, peeling and discoloring after usage over time