Z-1452-2015Class II

Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US)...

Name: Z-1452-2015 Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US)...
Creator: Integra LifeSciences Corp.
Published: 2015-03-13
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2015-03-13 / Terminated

FDA source

Integra LifeSciences Corp. began a recall of 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... on 2015-03-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1452-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-13
Posted: 2015-04-16
Terminated: 2016-04-13
Recalling firm: Integra LifeSciences Corporation
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.
Product code: KGN Wound Dressing With Animal-Derived Material(S)
Reason for recall: 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).
FDA root cause: Unknown/Undetermined by firm
Action: Integra Life Sciences Inc. sent a Recall letter/Recall acknowledgement and return form dated March 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Integra asks customers to review inventory and determine if any of the affected inventory is in possession. The attached Recall Acknowledgement and Return Form should be completed and returned. Customer service will contact the customer upon receipt of the form and provide an RMA number. Questions can be directed to Customer Service at 1-888-301-0203.
Quantity in commerce: 287 packages ( 179 US 108 OUS )
Distribution: 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.
Product codes and lots: Model Number FWD301 (US) & FDR301 (Non-US) The following Lot Numbers on the packaged kits are affected: - 305000293250, 305000293251, 305000298616 (foreign) The syringes within the packaged kits are also Lot numbered. For the packaged kit Lot Numbers above, the corresponding respective syringe Lot Numbers are: - 10500028786, 105000288118, 105N00288965 (foreign)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1452-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1452-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-16

Product code KGN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)