GENESIS — Class II medical device recall Z-0131-2014
Terminated recall by Smith & Nephew Inc, reported 2013-11-13, distributed nationwide. Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
| Recall number | Z-0131-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc, Memphis, TN, United States |
| Recall initiated | 2013-10-07 |
| Classified | 2013-11-01 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2016-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| Lot numbers | 13GM09505 |
| Model numbers | 71420188 |
Product
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
Reason for recall
Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
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-0131-2014. 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.