Events

Recall of AdVance Male Sling System

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

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
    63540
  • Event Risk Class
    Class 2
  • Event Number
    Z-0259-2013
  • Event Initiated Date
    2012-10-19
  • Event Date Posted
    2012-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114175
  • 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
    Mesh, surgical, polymeric - Product Code FTL
  • Reason
    American medical systems¿ (ams) is issuing a voluntary recall on a number of lots of the advance¿ male sling system (advance). ams has recently received a small number of complaints regarding the resorbable suture in the advance sling not lasting for the entire 15 month shelf life of the product. an internal investigation has been conducted and confirmed that some sutures degraded prior to the.
  • Action
    American Medical Systems sent an "URGENT MEDICAL DEVICE RECALL" dated October 18, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to return any existing stock of the recall product and to complete and return the Product Recall Acknowledgment Form. Contact AMS Customer Service at 1-800-328-3881 for additional information or questions. .

Device

AdVance Male Sling System
  • Model / Serial
    Part # Lot/Serial Range  720088-01 722022001 to 796127002 720088-02 722024001 to 790266012 72404224 742528001 to 795689010
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Croatia, India, Morocco, Mexico, Malaysia, Netherlands, New Zealand, Panama, Poland, Russian Federation, Solomon Islands, Singapore, Thailand, Turkey, Venezuela, South Africa, Chile, Colombia, Costa Rica, Slovenia, Argentina, China, and Taiwan.
  • Product Description
    AMS AdVance" Male Sling System || 720088-01 AMS AdVance" Male Sling System (US) || 720088-02 AMS AdVance" Male Sling System (Intl) || 72404224 AMS Male TO Sling System (Intl). || The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).
  • Manufacturer
    American Medical Systems, Inc.

Manufacturer

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