CLASS II ONGOING Device recall · Reported 29 Apr 2020 · FDA Enforcement Report

Footprint Ultra PK Suture Anchor recalled by Smith & Nephew

Smith & Nephew is recalling Smith & Nephew Footprint Ultra PK Suture Anchor, distributed nationwide in the US. The recall was initiated on 17 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled125,196 (Total)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1757-2020
FDA event ID: 85296
Recalling firm: Smith & Nephew, Mansfield, MA
Classification: Class II
Status: Ongoing
Recall initiated: 17 Mar 2020
FDA classified: 22 Apr 2020
Reported: 29 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Lead & Heavy Metals
Device type: Surgical Instruments

Timeline

17 Mar 2020	Recall initiated by company
22 Apr 2020	Classified by FDA	+36 days
29 Apr 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Alabama Arkansas California Colorado Illinois Montana Pennsylvania Puerto Rico

Questions about this recall

Is Footprint Ultra PK Suture Anchor recalled?

Yes. Smith & Nephew recalled Footprint Ultra PK Suture Anchor on 17 Mar 2020. The recall is Class II and its status is Ongoing. Recall number Z-1757-2020.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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