# FDA recall Z-1338-2019

> **Integra Limited** · Class II · device recall initiated 2019-03-31.

## Product

Integra Flowable Wound Matrix  Catalog No: FWD301    Product Usage:  Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.

## Reason for recall

Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months

## Distribution

Worldwide Distribution - US Nationwide  Foreign; Peru, Ecuador, Columbia, Brazil

## Key facts

- **Recall number:** Z-1338-2019
- **Recalling firm:** Integra Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-31
- **Report date:** 2019-05-22
- **Termination date:** 2020-05-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1338-2019

## Citation

> AI Analytics. FDA recall Z-1338-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1338-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*