HEALICOIL RSB SA 4 — Class II medical device recall Z-0169-2021
Ongoing recall by Smith & Nephew, Inc., reported 2020-10-28, distributed nationwide. Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a bre
| Recall number | Z-0169-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Andover, MA, United States |
| Recall initiated | 2020-09-09 |
| Classified | 2020-10-21 |
| Reported by FDA | 2020-10-28 |
| Distributed | Nationwide (US) |
| Quantity | 263,874 |
| Reason classes | sterility, packaging |
| Lot numbers | 2013957, 2013995, 2013996, 2016207, 2016209, 2017775, 2017860, 2018647, 2019852, 2019853, 2021462, 2023240, 2023345, 2024742, 2024841, 2025207, 2025370, 2025438, 2026562, 2027405, 2027434, 2027467, 2027500, 2029350, 2029351, 2030952, 2031022, 2031088, 2031089, 2031156, 2033536, 2034426, 2034498, 2035500, 2037151, 2037191, 2039451, 2039609, 2041070, 2042597 and 15 more |
Product
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
Reason for recall
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
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-0169-2021. 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.