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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Navinetics Inc: Skull Anchor Key and Drill Kit Recalled Due to Attachment Defect

Agency Publication Date: April 4, 2024
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Summary

Navinetics Inc has recalled 20 units of the NaviNetics Skull Anchor Key and Drill Kit, specifically model REF NN1215. The recall was initiated because the skull anchor key is defective, preventing medical staff from attaching the CT Localizer needed for stereotactic imaging. This problem occurs after the single-use anchor has already been attached to the patient, as the thumbscrews on the localizer cannot be screwed into the holes on the anchor key. Consumers and medical facilities should contact the manufacturer or their healthcare provider regarding this defect.

Risk

The inability to attach the CT localizer means that necessary brain imaging cannot be performed during a medical procedure. This failure occurs while the device is already attached to a patient, which could lead to surgical delays or the need for additional procedures to rectify the equipment failure.

What You Should Do

  1. Check your inventory for the NaviNetics Skull Anchor Key and Drill Kit with Reference Number (REF) NN1215.
  2. Verify if the kit is part of the affected batch by checking for UDI/DI 10850023620276 and Lot Number 331401724.
  3. Immediately stop using any kits matching these identifiers and secure them to prevent accidental use in a clinical setting.
  4. Contact Navinetics Inc or your healthcare provider for instructions on how to handle the defective units and to discuss potential replacements or refunds.
  5. For additional information, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) or visit the FDA medical device recall website.

Your Remedy Options

๐Ÿ“‹Other Action

manufacturer or healthcare provider consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Model / REF:
REF NN1215
UDI/DI 10850023620276
Lot Numbers:
331401724

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94163
Status: Active
Manufacturer: Navinetics Inc
Manufactured In: United States
Units Affected: 20 kits
Distributed To: Florida, Minnesota, Colorado

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.