American Medical Systems, Inc.

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.

General and Plastic Surgery Devices

2

Yes

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.

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

Finish Good Lot#'s P/N 720093-01 669201 669204 669205 669207 669210 670195 670200 670200 670201 670202 670203 670204 670205 670206 670207 670208 670210 670211 670212 670214 671296 671297 671298 671299 673583 673587 673588 673589 673594 673595 673598 673601 674863 674864 674865 674866 674867 674868 674869 674870 674871 674872 674873 674874 674875 674876 675816 675817 675818 675819 675820 675821 675822 675823 675824 675825 675826 675826 675827 675827 675828 675828 675829 675830 675830 675831 675832 675833 675834 675834 675835 675835 676042 676042 676867 676868 676869 676870 676871 676872 676873 676874 676875 676876 676877 676878 676879 676880 676881 676882 676883 676884 676885 676886 676887 676888 676888 676889 676890 676891 676891 677926 677927 677927 677928 677928 677929 677929 677930 677930 677931 677931 677932 677932 677933 677933 677934 677935 677935 677935 677936 677937 677938 677939 677939 677940 677941 677942 677943 677944 677945 677945 677946 677947 677948 677948 677949 679059 679059 679060 679060 679061 679062 679062 679063 679063 679064 679064 679065 679066 679066 679067 679068 679068 679069 679070 679070 679071 679071 679072 679073 679074 679075 679076 679077 679078 679078 679078 679079 679080 679080 680215 680216 680217 680218 680219 680220 680221 680222 680223 680224 680225 680226 680227 680228 680228 680229 680229 680230 680230 680231 680231 680232 681082 681083 681084 681088 681089 681090 681091 681092 681093 681094 681095 681096 681097 681098 681099 681100 681102 681103 681104 681106 682097 682098 682109 682110 683515 683516 683517 683518 683519 683520 683521 683522 683523 683524 683525 683526 683527 683528 683529 683530 683531 683532 683533 683534 683535 683536 683537 683538 683538 683539 683539 683540 683541 683542 683543 683544 683545 684502 684503 684504 684505 684506 684507 684508 684509 684510 684511 684512 684512 684513 684513 684514 684514 684515 684516 684517 684518 685708 685709 685710 685711 685712 685713 685714 685715 685715 685716 685716 685717 685718 685719 685720 685721 685721 685722 687025 687026 687027 687028 687029 687030 687031 687032 687032 687033 687033 687034 687034 687742 687743 687744 687745 687746 687746 687747 687747 687748 687748 687749 687749 687750 687750 687751 687752 687752 687752 687759 688958 688959 688959 688960 688960 688961 688962 688963 688964 688965 688965 688966 688967 688968 688969 688969 688970 688971 688971 688972 688972 688973 688974 688975 688975 688976 688977 688977 688978 688979 688979 688980 689838 689839 689840 689840 689841 689841 689842 689843 689844 689844 689845 689846 689847 689848 689849 689849 689850 689851 689852 689853 689854 689855 689856 689856 689857 689858 689858 689859 689860 689861 690462 690886 690887 690887 690888 690889 690890 690891 690892 690893 690893 690894 690895 690896 690896 690897 690898 690898 691283 691283 691284 691284 691284 691285 691285 691286 691286 691287 691287 691287 691288 691289 691290 691290 691291 691291 691292 691292 691293 691294 691294 691295 691295 691296 691296 691297 691297 691990 691991 691992 691992 691993 691993 691994 691994 691995 691996 691996 691996 691997 691998 691999 692000 692001 692002 692003 692004 692005 692005 692006 692007 692007 692008 692009 693640 693641 693642 693642 693643 693643 693644 693645 693646 693647 693648 693649 693650 693651 693651 693652 693653 693654 693655 693656 693657 693657 693658 693659 693660 693661 693661 693662 693663 693664 693665 693666 693667 694721 694729 694730 694730 694747 694747 694764 694767 694769 694770 694771 694772 694773 694776 694807 694808

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution -- USA (nationwide) including DC and Puerto Rico and countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, FRANCE, GERMANY, PORTUGAL SPAIN, UNITED KINGDOM, ARGENTINA, COLOMBIA, ESTONIA, FINLAND, GREECE, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NEW ZEALAND, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TAIWAN REPUBLIC OF CHINA, VENEZUELA

Elevate¿ System with IntePro¿ Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by:American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA || Product Usage: The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenteriological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. As configured, the Elevate Anterior device is used solely for prolapse repair

Gastroenterology-Urology Devices

3

Yes

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.

AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343 || InhibiZone Antibiotic Surface Treatment, AMS 800 Urinary Control Pump with InhibiZone, REF 72404127, Sterilization Method ETO, American Medical Systems Inc., 10700 Bren West, Minnetonka, MN 55343 || The AMS Urinary Control System (of which the pump is a component) is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.

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

Gastroenterology-Urology Devices

3

Yes

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.

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.