Events

Recall of AMS 700 Series Inflatable Penile Prosthesis Accessory Kit

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
    69536
  • Event Risk Class
    Class 2
  • Event Number
    Z-0209-2015
  • Event Initiated Date
    2014-10-10
  • Event Date Posted
    2014-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130885
  • 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
    Prosthesis, penis, inflatable - Product Code JCW
  • Reason
    Ams' supplier has issued a recall of certain lots of lightning bolt keith needles supplied in ams 700 accessory kits. based on this, ams is recalling ams 700 accessory kits which contain these lots of needles. the supplier made the decision to issue this recall after an internal investigation that was requested by ams. the investigation identified a potential nonconformity that may lead to a bent.
  • Action
    Consignees were sent via either Fed Ex mailing or hand delivery by AMS Field Personnel beginning on 10/10/2014 an AMS "Urgent Medical Device Recall" letter dated October 9, 2014. The letter described the problem and the product involved in the recall. Requested consignees to complete and return the Product Recall Acknowledgement Form. For questions consignees can contact AMS Customer Service at 1-800-328-3881 , FAX 1-800-366-9035, ore mail salesoperations@ammd.com.

Device

AMS 700 Series Inflatable Penile Prosthesis Accessory Kit
  • Model / Serial
    Lot Number 861912018 861914016 862631001 862639018 863952005 863960024 863962007 865584018 865585013 865593007 865869024 865882006 867705012 868952010 868961016 868962022 868964021 869672008 869673021 869683007 870935011 870935017 870936016 870936023 870937001 870938022 870940022 871927006 871927014 871930002 873243013 873243015 873247017 873253025 873944005 873945017 873946003 873949005 873950009 873951024 873952024 875055017 875060017 875060024 876016019 876025002 877253005 877259010 878159022 878160012 878162016 878164009 878165016 878168017 878168021 878975023 880215004 880217014 881145009 881146023 881149014 881150018 881152025 882234015 882236002 882239002 882240012 882241016 882243015 882245014 883312010 883313020 883315019 883319013 883319014 883319015 884416007 884416024 884420017 884422015 884422018 884423025 885166007 885166024 885170004 885170022 886256007 886256021 886257022 886260022 886260024 886260025 886261024 886262010 886263002 886263017 886264010 886264024 886848011 886848012 886849016 886855001 886855019 886858004 886858011 886858014 887908021 887909002 887909003 887909008 887910017 887912005 887912006 887915009 887917021 888755008 888755012 888758013 888762005 888762015 889654010 889656003 889656005 889656006 889656023 889657013 889657014 890573015 890573017 890576003 890577015 890578013 890579011 890579016 890580017 890581001 890581002 890581003 890581004 890581005 890581006 890581007 890581018 890581024 890582011 890582012 890582013 891506011 891506012 891507012 891507014 891507021 891508002 891508019 891508020 891508021 891509005 891509006 891510011 891511001 891511002 891513002 891513003 891513024 891515003 891516015 892497013 892497014 892498002 892501001 892501002 892501003 892501004 892501012 892501016 892501017 892501018 892501019 892501020 892501021 892501022 892501023 892501024 892501025
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (nationwide) including PR and the states of AL. AZ. AR, CA, CO, CT, IL, IN, KS, KY, MD, MA,MI, MN, MO, NY,NC, OH,OR, TN, TX, VA, and WA, and the countries of ARGENTINA, AUSTRALIA, BRAZIL, CANDA, GERMANY, FRANCE, GREAT BRITAIN, LEBANON, PANAMA, SOLOMON ISLANDS, SWEDEN, and COLOMBIA.
  • Product Description
    AMS 700¿ Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. || Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.
  • 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