Events

Recall of Device Recall AMS InteXen LP Collagen Dermal Matrix

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by American Medical Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50680
  • Event Risk Class
    Class 3
  • Event Number
    Z-0932-2009
  • Event Initiated Date
    2008-12-05
  • Event Date Posted
    2009-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75984
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Surgical Mesh - Product Code FTM
  • Reason
    The product size shown on the carton labeling does not match the size on the product inside.
  • 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.

Device

Device Recall AMS InteXen LP Collagen Dermal Matrix
  • Model / Serial
    lot/serial number: 567398002, 567398003
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of TN and TX.
  • Product Description
    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.
  • Manufacturer
    American Medical Systems

Manufacturer

American Medical Systems
  • Manufacturer Address
    American Medical Systems, 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA