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Recall Observatory FDA recall evidence

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

August 04, 2020

Class II

Product summary

Firm
Integra LifeSciences Corp.
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

    reason.no_named_rule · v1.0.0

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