NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 recallZ-1478-2024 · Navinetics Inc · initiated Feb 26, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Navinetics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1478-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 26, 2024
- Posted by the FDA
- Apr 4, 2024
- Recalling firm
- Navinetics Inc
- Quantity
- 20 kits
- Product code
- HAW
- FDA submissions
- K231392
- Distribution
- US Nationwide distribution in the states of FL, MN, CO.
Product description
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Code information (models, lots, serial numbers)
UDI/DI 10850023620276, Lot Number 331401724
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NaviNetics Skull Anchor Key and Drill NN1215Navinetics, Inc. · Neurological Stereotaxic Instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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