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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 66037
Product Type Devices
Status Ongoing
Recalling Firm Smith & Nephew, Inc. Endoscopy Division
City Andover
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-06
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor 50252371, 50252817, 50252818, 50253051, 50253556, 50254393, 50255140, 50255943, 50257230, 50257886, 50258390, 50258813, 50259145, 50259748, 50259820, 50260127, 50261934, 50263317, 50263909, 50264101, 50264417, 50264775, 50265257, 50265457, 50265935, 50266338, 50266709, 50266926, 50267287, 50267297, 50267742, 50268009, 50268284, 50268801, 50269502, 50269812, 50270227, 50270716, 50271271, 50271608, 50271908, 50272544, 50273015, 50273358, 50273640, 50273933, 50274557, 50274799, 50275368, 50276253, 50276254, 50276805, 50277029, 50277294, 50277527, 50277929, 50278456, 50278571, 50278899, 50279282, 50279628, 50279887, 50280270, 50280509, 50280951, 50281119, 50281654, 50281988, 50282538, 50282785, 50283315, 50283661, 50284261, 50284507, 50285047, 50285232, 50286292, 50286603, 50287484, 50287742, 50287951, 50288412, 50288413, 50288709, 50288711, 50289018, 50289361, 50289598, 50290037,50290863, 50291536, 50291656, 50292239, 50292240, 50292919, 50293285, 50293609, 50293897 50294168, 50294377, 50295055, 50295263 50296219 50296742 50297227 50297778 50297779 50297780 50298062 50298419 50298786 50299246 50299545 50299546 50299826 50300216 50300804 50301267 50301404 50302151 50302685 50303058 50303427 50303788 50303941 50304178 50304532 50305224 50305593 50306159 50306607 50306999 50307177 50307178 50307323 50307855 50308129 50308350 50308876 50309006 50309569 50309929 50310088 50310360 50310603 50311024 50311465 50311593 50312088 50312508 50312903 50313096 50313194 50313433 50313434 50313810 50313981 50314087 50314275 50314383 50314587 50314734 50314912 50315220 50315412 50315573 50316170 50316287 50316663 50316991 50317294 50317333 50317334 50319134 50319316 50319548 50319721 50320087 50320539 50320883 50321123 50321480 50321923 50322389 50322921 50323075 50323255 50323447 50323635 50323776 50324607 50326329 50327629 50327993 50331045 50328867 50329238 50331335 50331336 50331537 50332615 50332903 50333951 50334376 50335473 50336653 50337963 50338375 50339635 50340038 50340416 50340763 50342101 50343001 50344257 50345538 50347525 50348062 50348915 50349098 50349263 50350688 50350689 50350836 50352820 50353935 50354580 50355436 50356119 50356623 50357088 50357393 50357564 50357945 50358202 50358558 50359337 50360155 50360278 50361746 50362228 50363184 50363885 50364586 50365181 50366145 50367196 50367857 50369186 50370317 50370991 50371619 50372060 50373120 50373578 50374500 50375710 50376426 50376982 50377966 50378141 50378906 50379638 50380808 50381014 50382645 50383518 50385488 50388028 50388735 50391247 50392262 50393194 50393195 50393328 50394070 50395083 50396301 50396306 50397055 50397697 50398394 50399613 50400932 50401260 50402476 50403935 50405215 50406205 50407446 50410767 50411908 50412270 50413576 50415461 50416150 50417011 50418094 50420319 50423595 50423956 50426322 50427033 50428117 50429370 50429371 50429656 50430184 50430404 50434435 50436746 50437585 50438204 50439582 50441442 50441680 50443183 50443859 50445451 50445521 50445522 50446168 50447915 50448596 50449837 50450220 50451518 50451942 50455628 50457777 50458924 50461408 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 43385 US Z-2215-2013
BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor 50252956 50253511 50255944 50257231 50257887 50258391 50259146 50259750 50259821 50260686 50261428 50262956 50263219 50263661 50264102 50265258 50266339 50266927 50267570 50268569 50269026 50269813 50270372 50271272 50271909 50272355 50273934 50274664 50275118 50276255 50276806 50277167 50277785 50278253 50278900 50279470 50280271 50280510 50281120 50281481 50281875 50282158 50282541 50283320 50283827 50285048 50285421 50286293 50286609 50287487 50287743 50288414 50288712 50289363 50290038 50290548 50291351 50292241 50293608 50294169 50294378 50295261 50297038 50298069 50299385 50299683 50300671 50301473 50302325 50303059 50303150 50303787 50304658 50305102 50305723 50306820 50307460 50308223 50308654 50309005 50309760 50309927 50310434 50310774 50310860 50311917 50312590 50314382 50315219 50315411 50315799 50316169 50316263 50316662 50316990 50317055 50317280 50317454 50317458 50317464 50317995 50318784 50319133 50319545 50320231 50321239 50323634 50324606 50325731 50326560 50327214 50328866 50330833 50331688 50332902 50333546 50333779 50338800 50339831 50341603 50342909 50344379 50345301 50345318 50346210 50348330 50348512 50349830 50350260 50350691 50351144 50351956 50352210 50353153 50353605 50354092 50354530 50355121 50356403 50356622 50357089 50357390 50358104 50358384 50358570 50358737 50360444 50360805 50361888 50362229 50363185 50363892 50364660 50364943 50366146 50366306 50367859 50369187 50370318 50370807 50371620 50372061 50372503 50372895 50373328 50375326 50376603 50378048 50378139 50379043 50381196 50382147 50385218 50385487 50385823 50386382 50388029 50388738 50388904 50390494 50391246 50392389 50394523 50395091 50396670 50398546 50399426 50401028 50402074 50402820 50404404 50405090 50405697 50405889 50409820 50407935 50408209 50410766 50411053 50411900 50412271 50413139 50414779 50414982 50415491 50416313 50417008 50417522 50418330 50418858 50421496 50430179 50430392 50435315 50437094 50437346 50438202 50440209 50441677 50442744 50443592 50444060 50445031 50445515 50445520 50447262 50448595 50450276 50451218 50453799 50455193 50458413 50459732 50460345 50461686 50462370 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 24574 US Z-2216-2013
BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 Biodegradable suture anchor 50281125 50284266 50287760 50291931 50296472 50300113 50311609 50316176 50321099 50328710 50345983 50346630 50347152 50375169 50379044 50391248 50392390 50409415 50414558 50419568 50421350 50443184 50447005 50449127 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 1735 US Z-2217-2013
BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor 50253115 50253116 50253563 50258921 50259836 50261046 50261482 50266078 50266098 50266396 50266957 50270377 50271281 50273022 50274567 50281658 50291542 50293283 50298902 50302160 50304442 50308346 50310770 50323628 50328862 50348760 50349091 50350411 50353298 50359945 50360003 50361170 50361752 50364587 50366305 50380819 50382582 50386154 50387219 50387852 50388184 50388737 50389115 50389772 50417524 50452589 50464571 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 725 US Z-2218-2013
BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor 50257249 50266395 50266956 50273021 50274566 50292663 50298060 50310769 50312085 50312489 50314911 50319308 50320226 50365776 50366000 50372062 50372899 50373577 50430178 50430381 50432333 50433339 50435314 50437523 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 240 US Z-2219-2013
OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor 50261071 50265227 50268236 50270124 50270127 50270731 50270732 50270944 50272331 50272463 50272751 50274143 50274349 50277106 50278834 50281659 50282211 50282825 50283848 50285062 50287130 50288422 50289369 50291056 50292247 50293722 50295044 50295954 50297046 50298435 50299024 50301146 50301385 50302078 50306608 50307181 50307859 50308888 50308912 50309137 50311191 50312587 50314102 50315238 50316441 50316664 50317482 50317875 50318971 50319908 50320248 50321101 50321648 50322088 50322930 50323639 50324385 50325610 50325737 50326879 50327995 50328245 50329009 50329813 50330435 50332245 50333093 50333956 50334115 50334402 50335321 50336229 50336882 50337043 50337449 50338243 50338995 50339833 50340161 50341063 50341287 50341846 50342910 50343441 50344016 50344263 50344619 50346628 50347009 50347537 50348331 50349439 50350189 50350979 50351681 50351959 50352540 50353155 50353497 50353607 50354099 50355298 50355824 50356121 50356985 50357105 50357560 50358205 50358555 50359713 50360281 50360451 50361177 50362090 50362645 50362978 50363189 50363545 50364184 50364663 50364910 50364911 50364912 50369681 50369960 50370096 50370209 50371913 50373322 50373580 50374378 50375175 50375582 50375896 50376045 50376616 50376834 50377164 50377317 50379208 50379388 50379938 50380822 50381057 50381374 50381815 50382801 50383513 50384164 50384951 50385489 50385824 50386925 50387321 50387880 50387895 50388430 50389103 50390008 50390942 50391228 50391627 50392267 50392391 50393196 50393760 50394180 50396181 50396831 50397271 50397460 50398372 50398722 50399414 50399815 50400186 50400942 50401453 50401757 50401920 50402611 50402824 50403368 50403711 50403712 50404421 50404748 50405574 50406025 50406508 50407109 50407568 50408211 50408883 50410215 50409543 50409822 50410771 50411055 50412025 50412274 50412888 50413142 50413774 50414255 50414556 50415255 50415495 50415667 50415868 50416318 50416532 50416826 50417010 50417205 50417523 50418332 50419700 50420159 50420854 50421718 50423590 50423955 50425117 50426327 50426461 50426940 50427506 50427629 50428458 50428810 50430183 50430401 50430506 50430507 50430658 50430659 50430660 50430661 50431124 50431125 50431126 50431237 50431238 50431383 50431385 50433042 50433340 50435317 50435735 50436891 50437525 50437584 50438203 50438660 50438927 50439573 50439897 50440453 50441440 50441678 50442126 50442378 50444664 50445032 50445140 50445313 50445546 50445547 50446664 50447263 50448058 50448322 50448831 50450467 50450753 50450948 50451767 50451782 50452211 50452586 50453147 50453807 50454296 50454419 50454689 50455196 50455484 50455814 50456055 50456612 50456911 50457054 50457927 50458417 50458476 50459149 50459444 50460099 50460241 50461693 50461911 50462227 50462795 50463367 50463459 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 25733 Z-2220-2013
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor 50272329 50272466 50274208 50274464 50274790 50275814 50277799 50278266 50278994 50282166 50283019 50283839 50285057 50286656 50288421 50289813 50291359 50293118 50294563 50295608 50296649 50298065 50301017 50302318 50305467 50306821 50308347 50309211 50310089 50310614 50311296 50312591 50314389 50315223 50315419 50316180 50316679 50316987 50317481 50318376 50318532 50319543 50320363 50321935 50323084 50323631 50324184 50324789 50327218 50331339 50333094 50336659 50339177 50340628 50343607 50345140 50345975 50347750 50349688 50352034 50352998 50354277 50354523 50356122 50356984 50357948 50358554 50360002 50360656 50361750 50362641 50363887 50364918 50367858 50368809 50370314 50371912 50374779 50375720 50376835 50377822 50379209 50381376 50384165 50385364 50386748 50387839 50388736 50390940 50392275 50393329 50394520 50395793 50397073 50399277 50400560 50401454 50402073 50403117 50403703 50404630 50406026 50407298 50408207 50408986 50409815 50410646 50411754 50413578 50414258 50415462 50416319 50417212 50418095 50418678 50420659 50422216 50428378 50429372 50429659 50430185 50430406 50433943 50435810 50436716 50437246 50438205 50438744 50440212 50440606 50441444 50443360 50443860 50444062 50445142 50445316 50445551 50445552 50445553 50445555 50445556 50447139 50448325 50449126 50450279 50451524 50452588 50452764 50453646 50454691 50455485 50456543 50458419 50458609 50460107 50460693 50463955 50464113 50465465 50468475 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 17696 US Z-2221-2013
OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor 50272333 50272460 50272749 50273092 50274145 50274574 50277104 50277531 50278113 50281660 50283022 50283200 50283850 50285450 50287132 50290044 50290336 50292248 50293720 50295817 50298408 50301689 50302077 50305597 50307616 50307617 50307618 50307663 50308924 50308925 50308926 50309406 50309508 50310779 50311755 50312497 50314731 50316178 50316439 50317760 50318970 50320251 50320672 50321643 50321930 50322929 50324017 50325608 50326698 50327820 50329812 50331690 50332905 50334815 50336529 50339426 50340626 50341618 50343004 50343606 50344261 50344616 50346627 50350512 50351012 50351958 50353154 50353603 50354094 50355980 50356986 50358573 50359120 50360006 50360806 50361757 50362646 50363764 50364908 50364913 50364914 50370384 50372334 50372727 50372893 50374260 50375049 50375595 50378705 50378911 50379639 50380393 50380529 50383897 50384594 50385078 50385697 50387883 50388027 50388266 50389118 50390497 50392265 50394521 50395089 50395537 50397272 50397703 50399280 50400568 50401030 50401758 50402612 50403120 50403717 50404750 50405222 50406196 50407002 50407567 50407939 50408700 50409823 50411054 50412275 50413141 50414235 50415253 50415494 50416128 50416525 50417009 50417383 50418000 50418498 50419235 50421349 50423113 50423434 50425116 50426665 50426939 50427505 50429270 50430180 50431376 50433037 50433126 50434434 50435065 50435511 50438086 50438658 50439570 50440210 50441218 50442032 50444061 50444660 50445139 50445312 50445544 50445545 50446349 50447136 50448057 50449021 50449978 50449979 50449981 50449983 50449984 50449985 50450604 50450947 50451941 50452039 50453146 50453803 50454293 50454688 50455482 50455623 50456054 50456340 50456908 50458605 50460096 50460239 50461691 50462794 50463457 50466682 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 22879 US Z-2222-2013
OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor 50272332 50272462 50272750 50274144 50274350 50277105 50278907 50281510 50282171 50282827 50283849 50284637 50285830 50286658 50287767 50289371 50290043 50291934 50292091 50295383 50296070 50297228 50297782 50298793 50300135 50301932 50306856 50307462 50308037 50309210 50310436 50310780 50312090 50313439 50313818 50314915 50315807 50316601 50316986 50317483 50318001 50318687 50319907 50320679 50321916 50322244 50323257 50323630 50323780 50324608 50325611 50326067 50327821 50329242 50331546 50332253 50333092 50334400 50335620 50336405 50338241 50339832 50341062 50341605 50343271 50344262 50344618 50346215 50347305 50349093 50350513 50350978 50352032 50352701 50352997 50353606 50355123 50355672 50356987 50357104 50358206 50359714 50360454 50360914 50361413 50362647 50363190 50364588 50364909 50364915 50370316 50370385 50372675 50372728 50372892 50374025 50374503 50375408 50376044 50376238 50377316 50378706 50380530 50381197 50382647 50384163 50384950 50385362 50387220 50387886 50387896 50388742 50390996 50391608 50392266 50394701 50395538 50397273 50398231 50399415 50400574 50401262 50401918 50402459 50402823 50403367 50403718 50404238 50404920 50405868 50405869 50410769 50412026 50412957 50414254 50416317 50416526 50417204 50418001 50418331 50418992 50421031 50422577 50423435 50423591 50426460 50426933 50427032 50428116 50428624 50429271 50429999 50430000 50430400 50430503 50430504 50430505 50430657 50431379 50433038 50433039 50433040 50433041 50433127 50434653 50435732 50435733 50435734 50435809 50436890 50438659 50440452 50441439 50450277 50450752 50451781 50452210 50452585 50453453 50454295 50454418 50455195 50455483 50455813 50456909 50457385 50458416 50458475 50459739 50460097 50460240 50461060 50462482 50463458 50464108 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 18919 Z-2223-2013
OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor 50261490 50270751 50270752 50272328 50272465 50274463 50275816 50277797 50281885 50282824 50284636 50286043 50289368 50294562 50295821 50299025 50302162 50307324 50309971 50315070 50316291 50318787 50321649 50323781 50326576 50327051 50328246 50329605 50330164 50330433 50333202 50333957 50334241 50335882 50338130 50338996 50340050 50340627 50342110 50344240 50347147 50348649 50349265 50352033 50352702 50354093 50355668 50356988 50358386 50358575 50360455 50361180 50364371 50364916 50364917 50367984 50370095 50370386 50372674 50372726 50372891 50374024 50375338 50375718 50381375 50385219 50385825 50387844 50388265 50389117 50389773 50390998 50392274 50392409 50397270 50398235 50399412 50399967 50400564 50401261 50401755 50402841 50403705 50405380 50406766 50407937 50408210 50408987 50412272 50412887 50415149 50415668 50416533 50417385 50418091 50419236 50421032 50423918 50429649 50430508 50431561 50435318 50436414 50437095 50437757 50438661 50439575 50441219 50442379 50444209 50445033 50445549 50445550 50446028 50447137 50448059 50448721 50449649 50449999 50450468 50450949 50452587 50453337 50454420 50455626 50456613 50457636 50458477 50458757 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 6373 US Z-2224-2013
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor 50272330 50272467 50274209 50274465 50274791 50275815 50277800 50292667 50296071 50302316 50306994 50310605 50311297 50316179 50318681 50321243 50323086 50325048 50325601 50326880 50329010 50329811 50334408 50336660 50338997 50340629 50344015 50346092 50346624 50353156 50354524 50356989 50358564 50363890 50364919 50368628 50370206 50374882 50376601 50378711 50381816 50385513 50390999 50391628 50392410 50395539 50400939 50403274 50404746 50406677 50408208 50409818 50412886 50414333 50415150 50416320 50417391 50418417 50419567 50421499 50431562 50433945 50436052 50437097 50439085 50445036 50445557 50447140 50449470 50450754 50452349 50453811 50454844 50456056 50458436 50461697 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 5873 US Z-2225-2013
OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor 50272335 50272468 50274466 50274792 50275817 50278112 50282209 50283021 50286518 50286657 50286925 50288725 50290551 50291360 50294564 50295956 50296887 50298073 50301797 50307182 50309401 50309926 50310781 50312498 50314440 50319909 50320249 50322931 50323640 50325599 50326068 50329810 50329975 50333958 50335745 50338377 50341064 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 4452 US Z-2226-2013
OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor 50366964 50366974 50366982 50366987 50366991 50370758 50370941 50370943 50371293 50376477 50387447 50392962 50394696 50397924 50400302 50400308 50408067 50414256 50415787 50417207 50419579 50425118 50428815 50429654 50431732 50435075 50435211 50444669 50445035 50445761 50445877 50450950 50458418 50458435 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 4946 US Z-2227-2013
OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor 50364854 50366872 50366972 50366980 50366985 50366989 50370760 50370771 50370940 50371292 50376475 50385813 50386237 50386563 50386749 50388066 50391012 50394695 50396184 50400301 50400306 50400307 50403488 50404241 50406445 50407524 50407571 50410789 50411371 50414977 50415258 50415670 50416148 50417206 50418093 50418993 50420658 50423443 50429652 50430190 50430402 50431731 50433933 50435319 50441441 50442649 50444415 50445034 50445760 50447482 50448060 50448722 50450469 50451783 50453148 50454104 50455627 50456912 50458608 50460242 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 10296 US Z-2228-2013
TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 Biodegradable suture anchor 50324706 50324707 50324958 50325148 50326624 50336118 50336716 50336759 50337105 50337109 50337112 50339394 50339648 50339653 50339656 50339873 50341613 50343278 50344410 50346095 50350419 50352199 50357080 50358106 50358736 50359998 50361739 50362786 50363871 50366812 50368582 50370504 50372042 50374257 50376594 50378774 50380528 50382637 50384518 50386924 50388022 50390005 50390988 50392388 50395082 50395975 50396667 50398098 50401255 50402220 50404745 50406626 50406675 50408537 50411606 50414330 50415861 50417004 50418086 50422213 50428616 50429266 50429632 50436702 50436747 50436748 50438319 50438651 50438735 50438739 50438918 50445013 50446067 50446068 50446460 50446995 50448591 50450274 50451213 50453452 50453995 50456041 50456190 50457051 50458600 50462057 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 8889 US Z-2229-2013
TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202624 Biodegradable suture anchor 50324708 50325149 50326625 50336717 50337106 50339395 50339843 50341977 50344395 50348067 50349691 50350416 50352028 50353294 50354590 50356630 50358741 50360275 50362293 50363529 50368587 50371455 50374778 50376047 50379205 50382798 50385696 50387871 50388024 50390982 50392404 50395800 50400928 50403699 50405378 50408699 50410783 50415863 50417200 50418988 50429268 50429637 50429638 50429830 50430372 50431221 50438924 50439176 50439782 50440819 50442646 50442874 50446662 50447248 50448829 50449442 50449829 50450460 50451214 50452940 50453996 50456042 50456043 50456044 50456595 50458432 50458472 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 6985 US Z-2230-2013
TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor 50324715 50324960 50326833 50336719 50336768 50339643 50339651 50341854 50344396 50348650 50349838 50350841 50351449 50353295 50360151 50363875 50368586 50372045 50374017 50375716 50378770 50381624 50387868 50390937 50395330 50397700 50402973 50404638 50406692 50408058 50412954 50415137 50416799 50418989 50429269 50429640 50429642 50429832 50431134 50439753 50439754 50442740 50443625 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 3827 US Z-2231-2013
TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor 50325165 50326838 50336722 50339646 50339844 50343443 50350417 50352981 50379206 50397701 50429644 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 708 US Z-2232-2013
TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor 50324714 50324959 50325405 50336718 50336766 50337107 50337110 50339396 50339650 50339654 50339835 50340055 50341065 50341288 50341608 50341852 50341974 50343277 50344392 50345531 50346096 50349836 50350192 50351792 50355983 50356629 50357082 50358377 50358556 50359999 50360659 50361740 50362632 50363174 50363872 50366312 50367556 50368583 50369516 50370078 50370505 50371296 50371908 50372043 50372901 50373581 50376024 50376595 50377415 50378045 50378652 50379636 50379935 50381013 50381052 50382145 50383363 50384738 50384957 50385695 50388023 50388427 50388915 50390006 50390936 50391241 50391607 50392270 50392402 50394175 50394700 50395079 50395329 50395678 50396196 50397457 50399965 50400926 50401256 50402972 50403490 50404762 50405432 50405695 50406373 50406776 50407574 50410247 50410909 50411608 50413138 50413770 50414757 50415220 50415662 50416307 50416797 50417199 50417996 50420510 50421494 50421722 50429267 50429347 50429634 50429635 50430369 50433008 50433009 50433120 50433338 50438321 50438322 50438923 50438981 50438982 50440714 50441083 50444410 50446345 50446447 50446997 50448199 50449437 50449827 50450459 50450942 50451511 50451937 50456336 50457052 50457924 50458755 50459278 50459634 50459731 50462225 50467497 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 7148 US Z-2233-2013
TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor 50324716 50324717 50326836 50336720 50336769 50337108 50337111 50339644 50339652 50339655 50339836 50340060 50341066 50341289 50341609 50341853 50342712 50344393 50345532 50349940 50375176 50377968 50378734 50380398 50382028 50385516 50386564 50387848 50391713 50392430 50395097 50395980 50396847 50399973 50400923 50402846 50405227 50406208 50406714 50408995 50410652 50411391 50412536 50415225 50415871 50416543 50417398 50428649 50429274 50429621 50429622 50429871 50436765 50436775 50437663 50440391 50443629 50446032 50446451 50446454 50446455 50447009 50447010 50453524 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. Z-2234-2013
TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor 50325164 50326837 50336721 50336771 50339645 50339841 50341067 50341975 50344394 50349837 50350415 50351794 50359331 50363876 50368160 50370201 50372046 50375166 50377788 50378916 50380676 50381053 50388605 50392271 50392403 50395799 50403938 50411076 50417379 50422358 50433010 50433121 50438323 50448200 50460082 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 1308 US Z-2235-2013
TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor 50325166 50325167 50327043 50336737 50336772 50339647 50339842 50341976 50385698 50397465 50412290 50417528 50426452 50427818 50429624 50429874 50431563 50453525 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 1643 Z-2236-2013
RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor 50268918 50273148 50273920 50275809 50275812 50282175 50291658 50293289 50296525 50296650 50298707 50305798 50305840 50312502 50312528 50314834 50340632 50343203 50349591 50351817 50358580 50371915 50376235 50387881 50390367 50394081 50396639 50396640 50396641 50399818 50403721 50405089 50412292 50415521 50416545 50418333 50445533 50447145 50454703 50456549 50460175 50460177 50461710 50469565 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 1965 US Z-2237-2013
TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") with Needles; Part Number: 72202612 Biodegradable suture anchor 50373723 50389654 50389655 50397577 50397596 50397599 50397605 50417226 50431744 50431853 50433695 50437528 50440608 50441690 50447116 50447118 50447119 50448227 50454009 50454867 50461412 50467503 50469159 50470653 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 1571 US Z-2238-2013
TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor 50373722 50397580 50397597 50397602 50397606 50414780 50418109 50431745 50431893 50432157 50438518 50438520 50447115 50447117 50447120 50448228 50449526 50449671 50450004 50454012 50454109 50456362 50459638 50460185 50462233 50468656 50469160 50469533 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 2038 US Z-2239-2013
TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor 50373721 50375642 50397595 50397598 50397604 50397607 50449548 Class II Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. 314 US Z-2240-2013
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