Integra LifeSciences recalls 13 ft handpiece cables for Dermatome Sets Model S/S6 due to melting after sterilization. This poses a fire risk in medical settings. Affected units sold in hospitals and clinics.
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Integra LifeSciences is recalling 13-foot handpiece cables used in Dermatome Sets Model S and Model:6. The cables can melt after sterilization, creating a fire hazard in medical facilities where they're used for skin graft procedures.
The handpiece cable melts after sterilization, which can lead to electrical fires in medical settings. This hazard occurs during normal use in hospitals where the cables are sterilized for patient procedures.
Hospitals and clinics using Dermatome Sets Model S or S6 for skin graft procedures are affected. Medical staff using these cables for burn or plastic surgery treatments face the highest risk.
Check for the 13 ft handpiece cable with catalog number 353971513. These cables are part of Dermatome Sets Model S or S6 used in hospitals for skin graft procedures.
Inspect the cable for melting after sterilization, which may indicate it's unsafe.
Reach out to Integra LifeSciences for guidance on safe handling or replacement options.
The recall specifically addresses cables that melt after sterilization. Unsterilized cables are not affected by this hazard.
Look for the catalog number 353971513 on the cable, which is part of Dermatome Sets Model S or S6 used in hospitals.
The recall does not require immediate discontinuation; however, if the cable shows signs of melting after sterilization, it should be checked for safety.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2953-2020 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-2953-2020 from Integra LifeSciences. 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.
