Reported Sep 23, 2020 · Terminated

Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in…

Integra LifeSciences Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650

Is this the product you have?

  • Integra Padgett
  • Electric Dermatome Set - Product Usageare 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 under the supervision of trained personnel
Lot codes and dates
  • Catalog Number3539900
  • Catalog DescriptionElectric Dermatome Set Model #: S6 Lot/Serial #: S-594-6 NOT SOLD IN USA
Amount recalled
2 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Integra LifeSciences Corp. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 12, 2021 · Data as of Sep 19, 6:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.