NaviNetics Skull Anchor Key and Drill Kit — Class II medical device recall Z-1478-2024
Ongoing recall by Navinetics Inc, reported 2024-04-10, distributed nationwide. Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was u
| Recall number | Z-1478-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Navinetics Inc, Rochester, MN, United States |
| Recall initiated | 2024-02-26 |
| Classified | 2024-04-04 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 20 kits |
| UPC / GTIN / UDI-DI | 10850023620276 |
| Lot numbers | 331401724 |
| Model numbers | NN1215 |
Product
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Reason for recall
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.
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-1478-2024. 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.