Z-1478-2024Class II

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

Name: Z-1478-2024 NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Creator: Navinetics Inc
Published: 2024-02-26
License: https://open.fda.gov/license/

Navinetics Inc / initiated 2024-02-26 / Open, Classified / root cause: manufacturing process

FDA source

Navinetics Inc began a recall of NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 on 2024-02-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1478-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-26
Posted: 2024-04-04
Recalling firm: Navinetics Inc
Product: NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: NaviNetics issued an URGENT: NN1215 NAVINETICS SKULL ANCHOR KEY AND DRILL KIT RECALL notice to its consignees on 02/27/2024 via email. The notice explained the problem with the device, risk, and requested the return of the product.
Quantity in commerce: 20 kits
Distribution: US Nationwide distribution in the states of FL, MN, CO.
Product codes and lots: UDI/DI 10850023620276, Lot Number 331401724

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1478-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1478-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-04

Product code HAW

K231392Class IINaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc. / cleared 2023-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)