Device 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.
Z-2953-2020
Product summary
- Event
- Event 86240
- Status
- Terminated
- Classification
- Class II
- Quantity
- 74 units
- Official record key
device-enforcement:Z-2953-2020
Official wording
Reason: lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Code information: Catalog Number: 353971513 Catalog Description: Handpiece Power Cable Model #: N/A Lot/Serial #: PT-3195
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.