Genesis — Class II medical device recall Z-0118-2021
Terminated recall by Smith & Nephew, Inc., reported 2020-10-28, distributed nationwide. The anterior locking detail does not meet its design specifications.
| Recall number | Z-0118-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2020-09-21 |
| Classified | 2020-10-16 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2026-05-22 |
| Distributed | Nationwide (US) |
| Quantity | 47 devices |
| Lot numbers | 18JY09702 |
| Model numbers | 71420966 |
Product
Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
Reason for recall
The anterior locking detail does not meet its design specifications.
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-0118-2021. 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.