FDAAugust 4, 2020device
13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - 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 simi...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
What to do
FDA enforcement status: Terminated
Brands named
integra lifesciencesintegra
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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