FDA Device recall Z-0834-2019
Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
- FDA Device
- Class II
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class II recall of Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component by Signature Orthopedics, citing product mix up.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0834-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-10 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Signature Orthopedics |
| Distribution | US |
Product
Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
Reason
Product mix up
Identifiers
| code_info | UDI # 09348215020330 Device Model # 121-07-3000 Lot # 788F7-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0834-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.