Events

Recall of AMS Monarc Subfascial Hammock with Tensioning Suture

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
    69796
  • Event Risk Class
    Class 2
  • Event Number
    Z-0805-2015
  • Event Initiated Date
    2014-10-15
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131551
  • 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, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobtur - Product Code OTN
  • Reason
    During routine periodic packaging testing, ams identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the needle passer components supplied with the advance" male sling system; model # 720088-01; advance" xp male sling system; model # 720163-01; monarc" c subfacial hammock; model # 72404195; monarc" + subfacial hammock; model #.
  • Action
    Consignees were sent an AMS "Urgent Recall Notice" dated October 15, 2014. The letter was addressed to Physician, Health Care Professional, Nurse and Risk Manger. The letter described the problem and the product involved in the recall. Requested consignees to return all affected product and to complete and return the Acknowledgement Form. For questions, they can contact American Medical Systems Customer Service at 1-800-328-3881 (x6469). A second letter was available as optional communication to implanting physicians known by AMS to be regular users of the device. This physician letter was dated October 20, 2014.

Device

AMS Monarc Subfascial Hammock with Tensioning Suture
  • Model / Serial
    REF 72404195 Lot/Serial 858296001 to 897413030;  REF 72404193 Lot Serial 858292001 to 906172040
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, CROATIA, CECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SLOVENIA, SERBIA, SOUTH AFRICA, SPAIN. SWEDEN, SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, COLUMBIA, COSTA RICA, HONG KONG, MALAYSIA, MARTINIQUE, NEW ZEALAND, PANAMA, PHILIPPINES, SINGAPORE, THAILAND, VENEZUELA, CANADA, AUSTRALIA.
  • Product Description
    AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. || The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting of two stainless steel, curved needle passers. The tip portion of each needle passer is configured to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. The system also contains a sling assembly including one piece of loosely knitted polypropylene mesh, two removable plastic insertion sheaths attached to the mesh, and two connectors attached to the insertion sheaths. The mesh is constructed of polypropylene monofilament. An absorbable tensioning suture is threaded into the length of the mesh to allow for tensioning adjustment of the mesh after placement in the patient is achieved. The plastic covering also affords convenient travel of the mesh through the tissue. The connectors are attached to the tip portions of the Monarc needle passers during the procedure. The loosely knitted polypropylene mesh is intended to remain in the body as a permanent implant. The mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.
  • 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