HEALICOIL RSB SA 5 — Class II medical device recall Z-0173-2021
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-0173-2021 |
|---|---|
| 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 | 2013918, 2016156, 2017774, 2018804, 2021456, 2023227, 2024815, 2025049, 2027438, 2029400, 2029401, 2033290, 2033291, 2034431, 2034432, 2034499, 2034500, 2034501, 2034502, 2035698, 2037194, 2039456, 2045894, 2048429, 2048430, 2049950, 2049951, 2051045, 2051046, 2053927, 2056086, 2056434 |
Product
HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
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-0173-2021. 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.