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.
What this means for you
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 wil
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 2
Distribution
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.
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