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U.S. Department of Health and Human Services

Class 3 Device Recall AMS InteXen LP Collagen Dermal Matrix

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 Class 3 Recall
AMS InteXen LP Collagen Dermal Matrix
see related information
Date Posted January 27, 2009
Recall Status1 Open
Recall Number Z-0932-2009
Recall Event ID 50680
Premarket Notification
510(K) Number
K050445 
Product Classification Mesh, Surgical - Product Code FTM
Product AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The AMS collagen dermal matric is intended for use in the treatment of hernias where connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, or gastroenterological anatomy.
Code Information lot/serial number: 567398002, 567398003
Recalling Firm/
Manufacturer
American Medical Systems
10700 Bren Rd W
Minnetonka, Minnesota 55343-9679
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The product size shown on the carton labeling does not match the size on the product inside.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Customers were first notified by phone on 12/05/08. They were told of the situation and were requested to return the devices. Customers were also provided an Important Product Recall letter, dated 12/05/08. This letter identified affected product, told customers to discontinue use of product and to return it. An acknowledgement form was also asked to be returned. AMS Customer Service should be contacted at 1-800-328-3881 to receive a Return Authorization number and arrange for shipment of replacement product.
Quantity in Commerce 5
Distribution Nationwide Distribution --- including states of TN and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FTM and Original Applicant = AMERICAN MEDICAL SYSTEMS, INC.
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