Smith & Nephew GENESIS — Class II medical device recall Z-0573-2016
Terminated recall by Smith & Nephew, Inc., reported 2016-01-13, distributed in FL, IN, MO, TX. One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionall
| Recall number | Z-0573-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2015-11-09 |
| Classified | 2016-01-04 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-03-17 |
| Distributed | FL, IN, MO, TX |
| Quantity | 20 units |
| Reason classes | labeling |
| Lot numbers | 15GM07831 |
| Model numbers | 71934490 |
Product
Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.
Reason for recall
One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.
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-0573-2016. 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.