FDAClass IISeptember 23, 2020

Integra Padgett Dermatome Set - Product Usage: are recall

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.…

Why was Integra Padgett Dermatome Set - Product Usage: are recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.…
Recalling firm
Integra LifeSciences Corp.
Quantity
13 units
Distribution
Worldwide distribution - US Nationwide distribution including in the states of MN, TX, CA, UT, WV, FL, IN, GA, AZ, and the countries of Latin America ( CR, MX, TT, EC, PA ), Canada, Europe (FR, AT, BE, ES).
Recall date
September 23, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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