Recall Z-1478-2024 ยท HAW Neurological Stereotaxic Instrument
Navinetics Inc
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
| Date | Apr 4, 2024 (initiated Feb 26, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | 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 | 20 kits |
| Distribution | US Nationwide distribution in the states of FL, MN, CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231392 | NaviNetics Reusable Stereotactic System (NN1000) Navinetics, Inc., Jul 14, 2023 |