Integra recalls specific models of dermatome sets used in plastic surgery due to handpiece cable melting after sterilization. Affected units must be checked for melted cables and disposed of safely.
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Integra is recalling certain dermatome sets used in hospitals for skin graft procedures because the handpiece cable can melt after sterilization. This poses a risk of electrical hazards if the cable is damaged.
The handpiece cable melts after sterilization, which could cause electrical shorts or fire if the cable is damaged. This hazard occurs during normal medical use in hospitals.
Healthcare professionals using the Integra Padgett Dermatome Set in hospitals for skin graft procedures are most at risk. Patients under medical supervision are not directly affected.
Check for catalog numbers 3539700 with model S and lot/serial numbers S-1949 to S-1946 (including S-1927 and S-1928). These sets are sold only for professional medical use in hospitals.
Inspect the handpiece cable for melting after sterilization. If melted, stop using the device immediately.
Reach out to Integra LifeSciences for guidance on safe disposal or replacement of the affected units.
Integra LifeSciences identified that the handpiece cable melts after sterilization, which could cause electrical hazards.
No, patients are not directly affected as these devices are used only in hospitals under trained medical supervision.
Check for catalog number 3539700 with model S and lot/serial numbers S-1949 to S-1946 (including S-1927 and S-1928).
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-2954-2020 — Integra Integra Hello, I own a Integra that is covered by recall Z-2954-2020 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.
