FDA-Device2020-09-23Class II
Integra Padgett Dermatome Set - 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.
Integra LifeSciences Corp.
Hazard
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Sold states
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).
Affected count
13 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Integra Padgett Dermatome Set - 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2954-2020Don't want to check this manually?
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