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U.S. Department of Health and Human Services

Class 2 Device Recall Elevate Anterior and Apical Prolapse Repair Systems

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  Class 2 Device Recall Elevate Anterior and Apical Prolapse Repair Systems see related information
Date Initiated by Firm May 09, 2011
Date Posted July 07, 2011
Recall Status1 Terminated 3 on June 28, 2012
Recall Number Z-2755-2011
Recall Event ID 58850
510(K)Number K082677  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product 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
Code Information 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   
Recalling Firm/
Manufacturer		 American Medical Systems, Inc.
10700 Bren Road West
Minnetonka MN 55343-9679
For Additional Information Contact Mark Heggestad
952-930-6495
Manufacturer Reason
for Recall		 This is an important notification regarding the Elevate¿ Anterior and Apical Prolapse Repair Systems, Part Number 720093-01, manufactured between August 3, 2010 and January 17, 2011. We have recently received complaints stating that the eyelets were missing from the center graft of some units within the scope of this issue. The complaint rate to-date for the affected product is 0.045%, however th
FDA Determined
Cause 2		 Process control
Action American Medical Systems (AMS) sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 9, 2011 to all customers who received the recalled product. The letter identified the product, problem, and emphasize that the recalled product should not be implanted. The customers were instructed to examine their inventory for the recalled product and call AMS Customer Service at 1-800-328-3881 (select option 1) for an exchange of the product. For assistance in evaluating inventory the customers are instructed to contact their local AMS sales representative.
Quantity in Commerce 8563
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = AMERICAN MEDICAL SYSTEMS, INC.
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