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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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  Class 2 Device Recall Integra see related information
Date Initiated by Firm March 13, 2015
Date Posted April 16, 2015
Recall Status1 Terminated 3 on April 13, 2016
Recall Number Z-1452-2015
Recall Event ID 70758
Product Classification Dressing, wound, collagen - Product Code KGN
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.
Code Information 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) 
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Mr. David E. Gronostajski
609-275-0500
Manufacturer 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 Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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