Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4 — Class II medical device recall Z-1756-2020
Ongoing recall by Smith & Nephew, Inc., reported 2020-04-29, distributed nationwide. Space between the device and the packaging permits excessive movement which could potentially lead to the disp
| Recall number | Z-1756-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Mansfield, MA, United States |
| Recall initiated | 2020-03-17 |
| Classified | 2020-04-22 |
| Reported by FDA | 2020-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 125,196 |
| Reason classes | sterility |
| 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 and 397 more |
| Model numbers | 72202901 |
Product
Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1756-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.