FDA recall Z-2953-2020

Integra LifeSciences Corp. · Class II · 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.

Reason for recall

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

Distribution

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).

Key facts

Status
Terminated
Initiation date
2020-08-04
Report date
2020-09-23
Termination date
2021-08-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2953-2020