FDAFDA · Food and drugs·Recall number Z-1478-2024
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Published April 10, 2024 · Recall initiated: February 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Navinetics Inc
- Distributor
- US Nationwide distribution in the states of FL, MN, CO.
- Lot
- UDI/DI 10850023620276, Lot Number 331401724
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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