FDAClass IISeptember 23, 2020

Integra Padgett Electric Dermatome Set - Product Usage recall

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…

Why was Integra Padgett Electric Dermatome Set - Product Usage 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: 3539900 Catalog Description: Electric Dermatome Set Model #: S6 Lot/Serial #: S-594-6 NOT SOLD IN USA

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…
Recalling firm
Integra LifeSciences Corp.
Quantity
2 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)
Open FDA enforcement record Latest recalls