FDA Device recall Z-1478-2024
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 by Navinetics, citing defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Att….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1478-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-26 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Navinetics |
| Distribution | US |
Product
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Reason
Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically accomplished by fully screwing in the four thumbscrews of the localizer into the threaded holes found on the top surface of the Skull Anchor Key.
Identifiers
| code_info | UDI/DI 10850023620276, Lot Number 331401724 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1478-2024%22
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