HEALICOIL RSB SA 4 — Class II medical device recall Z-0168-2021
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-0168-2021 |
|---|---|
| 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 | 2013922, 2013943, 2013986, 2014657, 2016148, 2016204, 2016205, 2016243, 2017825, 2017855, 2017857, 2018750, 2018751, 2018810, 2020060, 2020061, 2020062, 2021052, 2021397, 2021459, 2021463, 2023236, 2023281, 2023282, 2023341, 2024736, 2024779, 2024781, 2024825, 2024827, 2024829, 2025052, 2025053, 2025199, 2025201, 2025430, 2027404, 2027433, 2027466, 2027499 and 68 more |
Product
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704
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-0168-2021. 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.