Integra Limited recalls Integra Flowable Wound Matrix Catalog No: FWD301 Product
Recalled 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.
Hazard / Issue
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
Issued by
FDA
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