# FDA recall Z-1478-2024

> **Navinetics Inc** · Class II · device recall initiated 2024-02-26.

## 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.

## Distribution

US Nationwide distribution in the states of FL, MN, CO.

## Key facts

- **Recall number:** Z-1478-2024
- **Recalling firm:** Navinetics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-26
- **Report date:** 2024-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1478-2024

## Citation

> AI Analytics. FDA recall Z-1478-2024. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1478-2024. Source: US FDA. Licensed CC0.

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