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U.S. Department of Health and Human Services

Class 2 Device Recall FOOTPRINT Ultra PH Suture Anchor 4.5

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  Class 2 Device Recall FOOTPRINT Ultra PH Suture Anchor 4.5 see related information
Date Initiated by Firm March 17, 2020
Create Date April 22, 2020
Recall Status1 Open3, Classified
Recall Number Z-1756-2020
Recall Event ID 85296
510(K)Number K093897  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5
Part Number: 72202901
Code Information 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 
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
130 & 120 Forbes Blvd
Mansfield MA 02048
For Additional Information Contact SAME AS ABOVE
508-261-3600
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Package design/selection
Action Smith & Nephew issued Urgent Medical Device Recall letter to International customers on March 17, 2020 and FedEx letters to US customers on March 18, 2020. Letter states reason for recall, health risk and action to take: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Urgent Medical Device Recall Notice, and quarantine them immediately.a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, please put an X in the appropriate location 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com or fax to +1-901-566-7975. Please Note  even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
Quantity in Commerce 125,196 (total)
Distribution Nationwide Foreign: AE AL AR AT AU BE BM BR CA CH CL CN CO CR CZ DE DK EC EE ES FI FR GB IE IL IN IT KR LT LV MT MX NO PA PE PL PR PT QA RU SE SG TH TR XK ZA
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = SMITH & NEPHEW INC., ENDOSCOPY DIV.
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