The Recall Desk
HighFDA (Devices)·Z-2954-2020·Announced 2020-09-23

Integra Padgett Dermatome Set Recalled Due to Cable Melting

Integra LifeSciences is recalling 13 dermatome sets because the handpiece cable melts after sterilization, posing a risk to patients and staff.

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 during use, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Integra LifeSciences Corp. is recalling 13 units of the Integra Padgett Dermatome Set (Catalog Number 3539700, Model S). The recall involves specific serial numbers: S-1949, S-1919, S-1930 to S-1932, S-1937 to S-1939, S-1944 to S-1946, and S-1927, S-1928. 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 received multiple complaints indicating that the handpiece cable melts following sterilization. This defect could compromise the integrity of the device during use. The affected units were distributed worldwide, including across the United States (MN, TX, CA, UT, WV, FL, IN, GA, AZ) and in Latin America, Canada, and Europe.

Healthcare facilities should stop using the affected dermatome sets immediately. Users should contact Integra LifeSciences Corp. for instructions on returning the devices or obtaining replacements. No injuries or illnesses have been reported in the source text.

The recalled product

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 unde
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 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

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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Same manufacturer · Integra LifeSciences Corp.

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Same hazard · melting

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