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Navinetics Inc recalls NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Recalled April 10, 2024 · FDA recall Z-1478-2024 · Navinetics
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. · FDA Class II
Units
20 kits
Sold at
US Nationwide distribution in the states of FL, MN, CO.
Description
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.
Product
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Manufacturer(s)
Navinetics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →