(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product… — Class II medical device recall Z-1418-2022
Terminated recall by Smith & Nephew, Inc., reported 2022-07-27, distributed nationwide. The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not m
| Recall number | Z-1418-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2022-06-27 |
| Classified | 2022-07-20 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2026-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 31 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 03596010206268, 03596010206350 |
| Lot numbers | 21DM14954S, 21FM13870A |
| Expiration dates | 2030-10-20 |
Product
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
Reason for recall
The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
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-1418-2022. 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.