FDA-Device2019-05-22Class II
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.
Integra Limited
Hazard
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
Sold states
Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil
Affected count
274 units
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1338-2019Don't want to check this manually?
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