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U.S. Department of Health and Human Services

Class 2 Device Recall The Acticon Neosphincter

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 Class 2 Recall
The Acticon Neosphincter
see related information
Date Posted June 27, 2011
Recall Status1 Terminated on July 06, 2012
Recall Number Z-2668-2011
Recall Event ID 58832
Premarket Approval
PMA Number
P010020
Product Classification Implanted Fecal Incontinence Device - Product Code MIP
Product AMS Acticon® Neosphincter Pump, Product Number 72402287, Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343. The Acticon Neosphincter is an implantable device used to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for less invasive forms of restorative therapy.
Code Information Lot Serial Number 479415015 484404007 484404008 479415001 441676011 456698011 588991014 599446004 599446008 618008001 618008009 656990003 688922003 690865009 416939013 459455017 660672019 451253005 546586004 546586005 546586006 601217007 601217008 660672005 434294009 416939002 430867008 430867010 430867015 434294015 441676009 441676017 459455019 522254014 430867011 430867016 441676003 479415006 484404005 681287002 434294008 434294013 430867006 433642013 434294011 537230009 588991002 618008010 632486010 690865001 690865005 554713002 681287001 635096008 477323017 484404001 546586009 580744007 587820013 587820018 529636010 450543002 415852010 656990009 434294006 491165014 491165015 528183002 544786016 571919013 610099003 493958005 635096006 660672020 508855001 587820020 451253004 533769015 580744004 459455009 484404016 493960002 571919001 593567017 601217001 601217002 601925008 618008008 631132003 441676006 508855008 528182003 528182016 631132004 462074004 462074005 462074006 462074007 462074008 593567001 433642010 434294017 587820001 450543007 450543008 451253006 451253007 451253008 456698005 456698008 456698010 456698019 467865015 416345004 462074002 529636003 546586002 580744019 587820007 632486006 635096009 688923007 528182006 546586001 522254011 528183006 533769007 537229002 544786007 546586003 571919011 580744014 610099008 647233007 414139011 484404011 522254018 451253010 424978004 450543018 467865020 539183003 554713003 580744016 610099010 533769003 533769008 529636004 588991008 660672016 395455007 529636006 631132010 554713016 462074012 462074013 493958008 493960006 512032004 528182002 528183008 533769006 537229001 539183005 554713005 571919004 587820009 588991005 406656002 456698004 681287008 451253002 479415010 528183012 462074001 462074003 479415002 593567002 544786008 414139014 593567013 601217003 647233005 681287003 358210006 571919019 477323018 528182011 539183008 533769001 580744018 544786001 580744002 673762006 522254007 651976004 430867013 434294010 651976010 462074010 433642005 467865012 433642008 508855004 660672010 462074015 467865017 467865018 467865019 477323020 529636011 456698003 528182019 647233009 384884002 408478005 477323010 508895006 554713014 528183004 554713012 580744003 632486007 651976006 681287004
Recalling Firm/
Manufacturer
American Medical Systems, Inc.
10700 Bren Road West
Minnetonka, Minnesota 55343-9679
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mark Heggestad
952-930-6495
Manufacturer Reason
for Recall
American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activa
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action American Medical System sent an "URGENT MEDICAL DEVICE RECALL letter dated May 9, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer Customers were instructed to return any existing stock . Please contact American Medical System at 1 (800) 328-3881 to obtain a Return Authorization number. Customer Service will also provide a FedEx shipping number for your use to return affected product. For further questions please contact American Medical Systems at 1- (800)328-3881.
Quantity in Commerce 225
Distribution Worldwide Distribution--USA (nationwide) including Washington D.C. and Puerto Rico and the countries FRANCE, GERMANY, CANADA, ISRAEL, SOUTH AFRICA, LEBANON, AUSTRIA, ARGENTINA, SAUDI ARABIA, SPAIN, BELGIUM NETHERLANDS, PERU, VENEZUELA, SRI LANKA, PORTUGAL, TUKEY, BRAZIL AUSTRALIA, CZECH REPUBLIC, TUNISIA. LUXWMBOURG, QATAR, SOLOMON ISLANDS, BOSNIA & HERZEGOVIA, CHILE, CHINA, COLOMBIA, COSTA RICA, DENMARK, ECUADOR, ESTONIA, FINLAND, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRELAND, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, POLND, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVAKIA, SLOVENIA, SWEDEN, SWITZERLAND, TAIWAN PROVIDENCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM and URUGUAY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MIP and Applicant = AMERICAN MEDICAL SYSTEMS, INC.
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