Integra Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (

FDA device recall Z-1452-2015 · posted 2015-04-16 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

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).

Action taken

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.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

KGN

Quantity affected

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.

Date initiated

2015-03-13

Date posted

2015-04-16

Date terminated

2016-04-13

Location

Plainsboro, NJ