FDAFDA · Food and drugs·Recall number Z-2953-2020
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.
Published September 23, 2020 · Recall initiated: August 4, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- 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).
- Lot
- Catalog Number: 353971513 Catalog Description: Handpiece Power Cable Model #: N/A Lot/Serial #: PT-3195
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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