GENESIS — Class II medical device recall Z-0447-2014
Terminated recall by Smith & Nephew Inc, reported 2013-12-11, distributed in NV. The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have
| Recall number | Z-0447-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc, Memphis, TN, United States |
| Recall initiated | 2013-08-27 |
| Classified | 2013-12-04 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2019-08-20 |
| Distributed | NV |
| Countries outside the US | AE, AU, BE, BG, DE, ES, FR, GB, IT, JP, NL, PL, TR |
| Quantity | 32 units |
| Lot numbers | 12GT20904 |
| Model numbers | 71421515 |
Product
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Reason for recall
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
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-0447-2014. 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.