Z-1478-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2024
- Initiation Date
- February 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 kits
Product Description
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
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 Pattern
US Nationwide distribution in the states of FL, MN, CO.
Code Information
UDI/DI 10850023620276, Lot Number 331401724