Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5
Medical device recall Z-1756-2020. Published in FDA’s Enforcement Report on Apr 29, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 29, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 125,196 (total) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
125,196 (total), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,994 characters
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…
FDA’s list runs to 3,748 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 17, 2020.
- FDA classified it on Apr 22, 2020.
- FDA’s Enforcement Report published it on Apr 29, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Smith & Nephew, Inc., of Mansfield, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,748 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.