Z-2954-2020Class II

Integra Padgett Dermatome Set -

Name: Z-2954-2020 Integra Padgett Dermatome Set -
Creator: Integra LifeSciences Corp.
Published: 2020-08-04
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2020-08-04 / Terminated / root cause: sterility

FDA source

Integra LifeSciences Corp. began a recall of 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... on 2020-08-04. FDA classified it as Class II and gives the reason as "lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2954-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-04
Posted: 2020-09-12
Terminated: 2021-08-12
Recalling firm: Integra LifeSciences Corporation
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.
Product code: GFD Dermatome
Reason for recall: lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Root cause tag: sterility
FDA root cause: Mixed-up of materials/components
Action: 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.
Quantity in commerce: 13 units
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).
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2954-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2953-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-11
Z-2954-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-11
Z-2955-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-11

Product code GFD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)