NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

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…

Recall #: Z-1478-2024
Affected scope: 20 kits
Initiated: February 26, 2024

Compiled from official public sources by the publisher. · Updated September 2026

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Navinetics Inc recalled NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 - a moderate-severity action.

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 was recalled by Navinetics Inc in April 10, 2024. Reason: Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was …. Check the official notice for the remedy. Verify recall #Z-1478-2024 with the FDA Devices before acting.

The recall

Navinetics Inc issued this moderate-severity FDA Devices recall-Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was ….

Moderate
severity level: Class II
classification: April 10, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1478-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-1478-2024
Date reported	April 10, 2024
Date initiated	February 26, 2024
Recalling firm	Navinetics Inc
Firm location	Rochester, MN
Affected scope	20 kits
Distribution	US Nationwide distribution in the states of FL, MN, CO.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1478-2024) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215. Recalled by Navinetics Inc. Units affected: 20 kits.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1478-2024.

Where was the recalled product distributed? ▼

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

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported April 10, 2024. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026