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Integra LifeSciences Corp. recalls 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: ar
Recalled September 23, 2020 · FDA recall Z-2953-2020 · Integra LifeSciences
Hazard
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. · FDA Class II
Units
74 units
Sold at
Worldwide distribution - US Nationwide distribution including in the states of MN, TX, CA, UT, WV, FL, IN, GA, AZ, and the countries of Latin America ( CR, MX, TT, EC, PA ), Canada, Europe (FR, AT, BE, ES).
Description
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
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.
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →