Recall Z-1452-2015— Integra LifeSciences Corp.

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2015-03-13, terminated 2016-04-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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)..

Recalling firm

Integra LifeSciences Corp.

Classification

Class II

Status

Terminated

Initiated

2015-03-13

Terminated

2016-04-13

Firm location

Plainsboro, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.