NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Reported: April 10, 2024 Initiated: February 26, 2024 #Z-1478-2024
Product Description
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
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.
Details
- Recalling Firm
- Navinetics Inc
- Units Affected
- 20 kits
- Distribution
- US Nationwide distribution in the states of FL, MN, CO.
- Location
- Rochester, MN
Frequently Asked Questions
What product was recalled? ▼
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215. Recalled by Navinetics Inc. Units affected: 20 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2024. Severity: Moderate. Recall number: Z-1478-2024.
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