Medical Device Recall: NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Navinetics Inc · February 26, 2024
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.
Distribution
US Nationwide distribution in the states of FL, MN, CO.
States Affected
NATIONWIDE
Quantity Affected
20 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1478-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.