Integra recalls electric dermatome sets used in hospitals for skin grafts due to handpiece cable melting after sterilization. Affected units sold outside the US; no remedy specified.
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Integra is recalling electric dermatome sets used in hospitals for skin grafts and burn treatments because the handpiece cable can melt after sterilization. This hazard poses a risk of electrical issues during medical procedures.
The handpiece cable melts after sterilization, potentially causing electrical shorts or fire hazards during medical procedures. This could lead to equipment failure or injury to patients or staff.
Healthcare professionals using these devices in hospitals or medical facilities for skin grafts and burn treatments. Patients under supervision are at risk if the device malfunctions.
Check for the model number S6 on the device. The catalog number is 3539900. These products were sold outside the United States and not available for purchase in the US.
Look for the model number S6 on the electric dermatome set.
No, these products were not sold in the United: Integra states they are not sold in the US.
The handpiece cable melts after sterilization, which could cause electrical shorts or fire hazards during medical procedures.
The recall does not specify a remedy, so no immediate action is required. However, healthcare professionals should monitor for cable melting.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-2955-2020 — Integra Integra Hello, I own a Integra that is covered by recall Z-2955-2020 from Integra. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
