—#183181

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.

FDA product code: GFD — Dermatome
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog Number: 353971513 Catalog Description: Handpiece Power Cable Model #: N/A Lot/Serial #: PT-3195

Why it was recalled

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

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

All impacted consignees will be notified by letter delivered by courier service, facsimile or email about the initial notification between August 4th and 6th, 2020. Customers are asked to remove the affected product from use and complete and return the response form to the manufacturer. After response forms are reviewed the customer will be asked to return the product and a replacement will be sent.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

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).

Timeline

Recall initiated: 2020-08-04
Posted by FDA: 2020-09-12
Terminated: 2021-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183181. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.