Navinetics Inc recalls NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

Recall date

February 26, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1478-2024

FDA classification

Class II

Brand / firm

Navinetics Inc

Sold / distributed

US Nationwide distribution in the states of FL, MN, CO.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215