Genius Knee Cemented CR Femoral Component Product Usage: Knee… — Class II medical device recall Z-0834-2019
Terminated recall by Signature Orthopedics Pty Limited, reported 2019-02-20, distributed nationwide. Product mix up
| Recall number | Z-0834-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Signature Orthopedics Pty Limited, Lane Cove West, N/A, Australia |
| Recall initiated | 2018-12-10 |
| Classified | 2019-02-14 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2020-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| UPC / GTIN / UDI-DI | 09348215020330 |
| Lot numbers | 788F7-1 |
| Model numbers | 121-07-3000 |
Product
Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
Reason for recall
Product mix up
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-0834-2019. 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.