FDA Device recall Z-0397-2022
VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
- FDA Device
- Class II
- terminated
- Published 2021-12-29
On 2021-12-29 the FDA classified a Class II recall of VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX by Civco Medical Instruments, citing there is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0397-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-08 |
| Published | 2021-12-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Civco Medical Instruments |
| Distribution | US |
Product
VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
Reason
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Identifiers
| code_info | Part Number 610-1080; UDI 00841436101936; Lot Numbers: A109102, A109175, A121363, A129087, A129088, A131042, A133436, A…Part Number 610-1080; UDI 00841436101936; Lot Numbers: A109102, A109175, A121363, A129087, A129088, A131042, A133436, A134220, A138099, A139369, A140674, A141818 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0397-2022%22
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