Class II — Navinetics Inc
| Recalling firm | NaviNetics Inc. |
|---|---|
| Registered facility | NAVINETICS INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 |
| Quantity | 20 kits |
| Distribution | US Nationwide distribution in the states of FL, MN, CO. |
| Initiated | 2024-02-26 |
| Classified | 2024-04-04 |
| Recall number | Z-1478-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Navinetics Inc (Z-1478-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94163/
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