FDAClass IIMay 22, 2019

Integra Flowable Wound Matrix recall

Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or…

Why was Integra Flowable Wound Matrix recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: 2991332

Product
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or…
Recalling firm
Integra Limited
Quantity
274 units
Distribution
Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil
Recall date
May 22, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls