Z-0932-2009

AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile...

Name: Z-0932-2009 AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile...
Creator: American Medical Systems
Published: 2008-12-05
License: https://open.fda.gov/license/

American Medical Systems, Inc. / initiated 2008-12-05 / Terminated / root cause: labeling and UDI

FDA source

American Medical Systems began a recall of 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... on 2008-12-05. The reason FDA records is "The product size shown on the carton labeling does not match the size on the product inside". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0932-2009
Status: Terminated
Initiated: 2008-12-05
Posted: 2009-01-27
Terminated: 2012-06-05
Recalling firm: American Medical Systems, Inc.
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.
Product code: FTM Mesh, Surgical
Reason for recall: The product size shown on the carton labeling does not match the size on the product inside.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: lot/serial number: 567398002, 567398003

Product code FTM

K050445Class IIAms Collagen Dermal MatrixAmerican Medical Systems, Inc. / cleared 2005-06-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)