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
    56846
  • Event Risk Class
    Class 2
  • Event Number
    Z-0808-2011
  • Event Initiated Date
    2010-09-07
  • Event Date Posted
    2010-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94623
  • 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
    Polymeric Surgical Mesh - Product Code FTL
  • Reason
    American medical systems (ams) is recalling all lots of the advance male sling system with an expiration date between july 2012 and august 2013. internal testing has indicated the potential for degradation of the bioabsorbable tensioning sutures when the product is stored for longer than 15 months after the date of manufacture.
  • Action
    Consignees were sent an AMS "Urgent Product Recall" letter dated September 7, 2010. The letter described the problem and the product involved. They requested consignees to return any existing stock product and to return the Product Recall Acknowledgement form enclosed. Customers may request a credit or a full refund or also, arrange for replenishment of AdVance product. Questions regarding the recall should be directed towards AMS Customer Service at 1-800-328-3881.

Device

AdVance Male Sling System
  • Model / Serial
    The affected Lot Serial Number Range is 615445001 - 669783001 (The Lot Serial Number is comprised of nine digits. The first 6 digists represent the parent lot number, followed by the last 3 digits which represents the serial number). All lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- All states in the Continental USA including DC and Puerto Rico and countries of ARGENTINA, AUSTRIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, GERMANY, ESTONIA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HONG KONG, CROATIA, IRELAND, ISRAEL, INDIA, ITALY, REPUBLIC OF KOREA, LEBANON, MOROCCO, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, PANAMA, POLAND, PORTUGAL, RUSSIAN FEDERATION SAUDI ARABIA, SWEDEN SINGAPORE, SLOVENIA, THAILAND, TURKEY, TAIWAN, VENEZUELA, and SOUTH AFRICA.
  • Product Description
    Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL. || Sterilization Method ETO, American Medical systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA
  • Manufacturer
    American Medical Systems, Inc.

Manufacturer

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