Summary
The FDA issued a Class II for NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 by Navinetics Inc. 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 perf.
Details
Source
Device Recall
External ID
Z-1478-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Lot/Code Info: UDI/DI 10850023620276, Lot Number 331401724
Quantity Affected: 20 kits
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
US Nationwide distribution in the states of FL, MN, CO.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-26
Company
Rochester, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Navinetics Inc has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Navinetics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Navinetics Inc have FDA actions?
Navinetics Inc has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1478-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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