# FDA recall Z-2954-2020

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2020-08-04.

## 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.

## Reason for recall

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

## 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).

## Key facts

- **Recall number:** Z-2954-2020
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-04
- **Report date:** 2020-09-23
- **Termination date:** 2021-08-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2954-2020

## Citation

> AI Analytics. FDA recall Z-2954-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2954-2020. Source: US FDA. Licensed CC0.

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