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U.S. Department of Health and Human Services

Class 2 Device Recall NaviNetics Skull Anchor Key and Drill Kit

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  Class 2 Device Recall NaviNetics Skull Anchor Key and Drill Kit see related information
Date Initiated by Firm February 26, 2024
Date Posted April 04, 2024
Recall Status1 Open3, Classified
Recall Number Z-1478-2024
Recall Event ID 94163
510(K)Number K231392  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Code Information UDI/DI 10850023620276, Lot Number 331401724
Recalling Firm/
Navinetics Inc
206 S Broadway Ste 700
Rochester MN 55904
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = NaviNetics Inc.