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

Recall date

March 31, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1338-2019

FDA classification

Class II

Brand / firm

Integra Limited

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.