Navinetics Inc: Medical Device Recall in 2024 - (Recall #: Z-1478-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

Product Classification:

Class II

Date Initiated: February 26, 2024

Date Posted: April 10, 2024

Recall Number: Z-1478-2024

Event ID: 94163

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.

Status: Ongoing

Product Quantity: 20 kits

Code Information:

UDI/DI 10850023620276, Lot Number 331401724

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated