Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NaviNetics Skull Anchor Key and Drill Kit Recalled by Navinetics Inc Due to Defective Skull Anchor Key. After attachment of the...

Date: February 26, 2024
Company: Navinetics Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Navinetics Inc directly.

Affected Products

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

Quantity: 20 kits

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Navinetics Inc

Navinetics Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report