Integra Limited recalls Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the

Recalled May 22, 2019 · FDA recall Z-1338-2019 · Integra

Hazard

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

Units

274 units

Sold at

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

Description

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

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.

Manufacturer(s)

Integra Limited

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →