Recall Z-1478-2024— Navinetics Inc

Name: FDA recall Z-1478-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-26

Class II · Ongoing

Class II FDA medical device recall by Navinetics Inc, initiated 2024-02-26. It names one FDA 510(k) clearance: K231392. Product: NaviNetics Skull Anchor Key and Drill Kit, REF NN1215. 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 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..

Recalling firm: Navinetics Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-02-26
Firm location: Rochester, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K231392 — NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc.·cleared 2023-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.