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Open, Classified

NaviNetics Skull Anchor Key and Drill Kit, REF NN1215

FDA Recall Z-1478-2024 · Posted 2024-04-04

Recalling FirmNavinetics Inc
Recall StatusOpen, Classified
Product CodeHAW
Date Initiated2024-02-26
Product Quantity20 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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of FL, MN, CO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K231392NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc. · 2023-07-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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