medical Class II Updated 2020-09-23

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

Recalled Product

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.

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: 3539700 Catalog Description: Slimline Dermatome Set Model #: S Lot/Serial #: S-1949, S-1919, S-1930 to S-1932, S-1937 to S-1939, S-1944 to S-1946 ***Updated 5/3/21*** S-1927, S-1928

View official government recall

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