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

Agency Publication Date: September 12, 2020

Affected Products

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.

Catalog Number: 353971513 Catalog Description: Handpiece Power Cable Model #: N/A Lot/Serial #: PT-3195

Product: Integra Padgett Dermatome Set - 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.

Catalog Number: 3539700 Catalog Description: Slimline Dermatome Set Model #: S Lot/Serial #: S-1949, S-1919, S-1930 to S-1932, S-1937 to S-1939, S-1944 to S-1946 ***Updated 5/3/21*** S-1927, S-1928

Product: Integra Padgett Electric Dermatome Set - 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.

Catalog Number: 3539900 Catalog Description: Electric Dermatome Set Model #: S6 Lot/Serial #: S-594-6 NOT SOLD IN USA

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86240

Status: Resolved

Manufacturer: Integra LifeSciences Corp.

Manufactured In: United States

Units Affected: 3 products (74 units; 13 units; 2 units)

Agency Last Updated: May 3, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Catalog Number: 353971513 Catalog Description: Handpiece Power Cable Model #: N/A Lot/Serial #: PT-3195

Catalog Number: 3539700 Catalog Description: Slimline Dermatome Set Model #: S Lot/Serial #: S-1949, S-1919, S-1930 to S-1932, S-1937 to S-1939, S-1944 to S-1946 ***Updated 5/3/21*** S-1927, S-1928

Catalog Number: 3539900 Catalog Description: Electric Dermatome Set Model #: S6 Lot/Serial #: S-594-6 NOT SOLD IN USA