Reported Apr 10, 2024 · Ongoing

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

Navinetics Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Navinetics Inc · 206 S Broadway Ste 700 · Rochester, MN · 55904

Is this the product you have?

  • NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Lot codes and dates
    • UDI/DI 10850023620276
    • Lot Number 331401724
Amount recalled
20 kits

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:46 PM UTC

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