FDA Device recall Z-2955-2020
Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/o…
- FDA Device
- Class II
- terminated
- Published 2020-09-23
On 2020-09-23 the FDA classified a Class II recall of Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/o… by Integra Lifesciences, citing lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2955-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-04 |
| Published | 2020-09-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
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.
Reason
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Identifiers
| code_info | Catalog Number: 3539900 Catalog Description: Electric Dermatome Set Model #: S6 Lot/Serial #: S-594-6 NOT SOLD IN USA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2955-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.