Integra LifeSciences Corp. recalls 13 ft Handpiece Cable, component of the Dermatome Sets Model
Recalled Product
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 similar medical facilities, where the patient will be under the supervision of trained personnel.
Hazard / Issue
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Issued by
FDA
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