medical Class II Updated 2020-09-23

Integra LifeSciences Corp. recalls Integra Padgett Electric Dermatome Set - Product Usage: are

Recalled Product

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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: 3539900 Catalog Description: Electric Dermatome Set Model #: S6 Lot/Serial #: S-594-6 NOT SOLD IN USA
View official government recall

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