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Recall Observatory FDA recall evidence

Device product

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

Z-1478-2024

February 26, 2024

Class II

Product summary

Firm
Navinetics Inc
Event
Event 94163
Status
Ongoing
Classification
Class II
Quantity
20 kits
Official record key
device-enforcement:Z-1478-2024

Official wording

Reason: 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.

Code information: UDI/DI 10850023620276, Lot Number 331401724

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.