medical Class II Updated 2019-05-22

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

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: 2991332
View official government recall

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