NaviNetics recall
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Why was NaviNetics 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 10850023620276, Lot Number 331401724
- Product
- NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
- Recalling firm
- Navinetics Inc
- Quantity
- 20 kits
- Distribution
- US Nationwide distribution in the states of FL, MN, CO.
- Recall date
- April 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)