Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use Recalled by Integra LifeSciences Corp. Due to A lot of Flowable Wound Matrix that has...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.
Affected Products
Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Luer-Lok" connector Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.
Quantity: 287 packages ( 179 US 108 OUS )
Why Was This Recalled?
A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe).
Where Was This Sold?
Worldwide Distribution - US Distribution and to the countries of and to the countries of Greece, France, Italy, Spain, Switzerland, South America, Turkey and United Kingdom.
About Integra LifeSciences Corp.
Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report