Device product
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.
Z-2954-2020
Product summary
- Event
- Event 86240
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-2954-2020
Official wording
Reason: lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Code information: Catalog Number: 3539700 Catalog Description: Slimline Dermatome Set Model #: S Lot/Serial #: S-1949, S-1919, S-1930 to S-1932, S-1937 to S-1939, S-1944 to S-1946 ***Updated 5/3/21*** S-1927, S-1928
Distribution pattern: 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).
Derived failure modes
-
Unknown
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.