Integra LifeSciences Corp.: Medical Device Recall in 2020 - (Recall #: Z-2953-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 4, 2020

Date Posted: September 23, 2020

Recall Number: Z-2953-2020

Event ID: 86240

Reason for Recall:

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

Status: Terminated

Product Quantity: 74 units

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).

Voluntary or Mandated:

Voluntary: Firm initiated