Z-2953-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2020
- Initiation Date
- August 4, 2020
- Termination Date
- August 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 units
Product Description
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.
Reason for Recall
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
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).
Code Information
Catalog Number: 353971513 Catalog Description: Handpiece Power Cable Model #: N/A Lot/Serial #: PT-3195