smith&nephew GENESIS — Class II medical device recall Z-2163-2018
Terminated recall by Smith & Nephew, Inc., reported 2018-06-20. One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
| Recall number | Z-2163-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2018-05-04 |
| Classified | 2018-06-11 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2019-02-22 |
| Countries outside the US | AE, ES, MX |
| Quantity | 5 units |
| Model numbers | 71440408 |
Product
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Reason for recall
One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
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-2163-2018. 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.