The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2955-2020·Announced 2020-09-23

Integra Padgett Electric Dermatome Set Recalled Due to Cable Melting

Integra LifeSciences is recalling 2 units of the Padgett Electric Dermatome Set because the handpiece cable melts after sterilization.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (cable melting) that poses a risk of harm to patients or staff, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Integra LifeSciences Corp. is recalling 2 units of the Integra Padgett Electric Dermatome Set (Catalog Number: 3539900, Model #: S6, Lot/Serial #: S-594-6). These instruments are intended for professional use in hospitals and similar medical facilities for cutting skin grafts in plastic surgery and burn treatment.

The recall was initiated after the company identified through multiple complaints that the handpiece cable melts following sterilization. The affected units were distributed worldwide, including in the United States (specifically MN, TX, CA, UT, WV, FL, IN, GA, AZ) and in countries across Latin America, Canada, and Europe.

Healthcare facilities should stop using the affected dermatome sets and contact the recalling firm for instructions on how to proceed.

The recalled product

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…
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
2

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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