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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Smith & Nephew, Inc.: Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.; Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create a sterile breach.

Agency Publication Date: April 22, 2020
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Affected Products

Product: Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901

Lot Numbers: 2012020 2012021 2012022 2013822 2013823 2013887 2013888 2013914 2013915 2013954 2016801 2017394 2017397 2017401 2017759 2017760 2017763 2017764 2017768 2017771 2017815 2017816 2017817 2017846 2017847 2017848 2017849 2018638 2018742 2018799 2018800 2018853 2019892 2019991 2020052 2021389 2021498 2021546 2023225 2023273 2023274 2023336 2023337 2024762 2024764 2024806 2024808 2025068 2025070 2025157 2025160 2025163 2025290 2025291 2025342 2026561 2027397 2027428 2027460 2028121 2028122 2028618 2028619 2028749 2028750 2028751 2029248 2029249 2029250 2029291 2029292 2029293 2029294 2029334 2029335 2029336 2029383 2029384 2029385 2030933 2030934 2030935 2030936 2031067 2031068 2031069 2031070 2031071 2031072 2031073 2031074 2031075 2031076 2031141 2031142 2031143 2031144 2032807 2032808 2032809 2032810 2032811 2033267 2033268 2033269 2033270 2033271 2033382 2033383 2033384 2033385 2033386 2033514 2033515 2033516 2033663 2034412 2034413 2034414 2034415 2034416 2034477 2034478 2034479 2034480 2034481 2035480 2035481 2035482 2035483 2035484 2036292 2036293 2036294 2036295 2036296 2036297 2036698 2036699 2036700 2037117 2037118 2037119 2037120 2037121 2037170 2038309 2038310 2038311 2038312 2038442 2038443 2038445 2038446 2038447 2038782 2038783 2038914 2038915 2039242 2039243 2039244 2039432 2039433 2039434 2039592 2039593 2039594 2040094 2040095 2040096 2040722 2040723 2040724 2040725 2040726 2041191 2041192 2041193 2041431 2041547 2041777 2041778 2042760 2042761 2042762 2044877 2044878 2044879 2044880 2044881 2044882 2044883 2045839 2045840 2045841 2045842 50721044 50721045 50721046 50721227 50721228 50721919 50721920 50721921 50721922 50722408 50723098 50723389 50723390 50723723 50724821 50725276 50725277 50725278 50725279 50725989 50726256 50726257 50726260 50726261 50726557 50727072 50727077 50727078 50727524 50727525 50730874 50730875 50734022 50734023 50734024 50734030 50734033 50734034 50734036 50734037 50734039 50734040 50734042 50734043 50735323 50736230 50736233 50736235 50736236 50736237 50737179 50738897 50739104 50740014 50740015 50740167 50740168 50740169 50741211 50741832 50741833 50741834 50741835 50742583 50742584 50743462 50743463 50743738 50743739 50744055 50744056 50744328 50744329 50744775 50744776 50745436 50745437 50745438 50746626 50746627 50746801 50746802 50746803 50746804 50746806 50748497 50751200 50751201 50752128 50752129 50753568 50753569 50753570 50753571 50754486 50754487 50754493 50754494 50754495 50755636 50755851 50755852 50755853 50755854 50755855 50755997 50756146 50756147 50756148 50756149 50757521 50757522 50757523 50757525 50757733 50757738 50757739 50757740 50757742 50758325 50758326 50758327 50759485 50759486 50761327 50761857 50761860 50761863 50762247 50762248 50763843 50763845 50763849 50763861 50763862 50763864 50764542 50764753 50764754 50765679 50765680 50765941 50765942 50766196 50766197 50766198 50766562 50766563 50767112 50767113 50767823 50767824 50769322 50769323 50769324 50769325 50770401 50770402 50770798 50770799 50771037 50771038 50771157 50771158 50773884 50773885 50773886 50773887 50774343 50781296 50781297 50781996 50781997 50783242 50783243 50783244 50783246 50783247 50783249 50783779 50783780 50784093 50784094 50784095 50784394 50784395 50785260 50785503 50786022 50787963 50787964 50787965 50787966 50787967 50787968 50787969 50788373 50788682 50793414 50793415 50793416 50793870 50795928 50795929 50795934 50795935 50800432 50800433 50801025 50802121 50803206 50803207 50806300 50806302 50806303 50807428 50807429 50811206 50811208 50812377 50815363 50815808 50821887 50821888 50821890 50821891 50829130 50829131 50829132 50829133 50829134 50829135 50831610 50831611 50831981 50831982 50831984 50831985 50837351 50837352

Lot Numbers:
Numbers
Product: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902

Lot Numbers: 2013889 2013916 2013955 2014296 2016197 2016198 2016232 2016233 2016234 2017395 2017761 2017818 2017819 2018639 2018801 2018855 2019841 2019893 2019992 2021327 2021390 2021391 2021499 2022264 2022265 2022266 2022267 2024809 2025064 2025065 2025165 2025169 2025343 2025386 2027398 2027429 2028620 2029251 2029252 2029253 2029254 2029295 2029296 2029297 2029298 2029337 2029338 2029339 2029340 2029386 2029387 2030937 2030938 2030939 2030940 2031077 2031078 2031079 2031080 2031145 2032812 2032813 2032814 2032815 2033272 2033273 2033387 2033388 2033389 2033390 2033391 2033517 2033518 2033519 2033520 2033521 2033522 2033523 2033524 2033525 2033526 2033527 2033528 2033664 2034417 2034418 2034482 2034483 2036298 2036299 2036704 2036705 2037123 2037124 2037125 2037171 2037176 2038315 2038316 2038449 2038452 2038785 2038786 2038787 2038788 2038919 2039245 2039247 2039436 2039437 2039438 2040097 2040098 2040099 2040100 2040101 2040727 2040728 2040729 2041051 2041052 2041053 2041054 2041055 2041194 2041195 2041196 2041197 2041198 2041780 2041781 2041782 2042582 2042583 2042584 2042763 2042764 2042765 2044884 2044885 2044886 2044887 2044888 2045848 50532035 50598665 50670645 50721923 50721924 50722153 50722409 50723724 50723725 50723729 50724822 50725155 50725156 50726258 50726558 50726559 50730869 50730870 50730871 50730872 50730876 50730877 50734025 50734026 50734031 50734035 50734038 50734041 50736231 50736234 50737178 50737941 50737942 50738087 50738088 50738894 50738895 50738896 50742394 50742585 50742586 50744052 50744053 50744054 50744777 50745439 50745440 50745441 50746623 50746624 50746625 50747145 50747146 50747859 50747860 50748081 50748082 50748083 50748084 50751684 50753515 50753518 50760611 50760612 50760613 50760614 50760802 50760803 50760805 50760806 50760807 50766818 50766828 50769166 50769167 50769168 50773888 50774344 50776630 50776631 50785146 50785147 50785261 50785262 50785263 50785505 50785506 50793871 50795930 50795933 50795936 50803204 50803205 50807430 50807431 50811207 50811209 50815810 50815812 50821889 50821892 50831271 50831742

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85296
Status: Active
Manufacturer: Smith & Nephew, Inc.
Manufactured In: United States
Units Affected: 2 products (125,196 (total); 125,196 (Total))

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.