NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
FDA device recall Z-1478-2024 · posted 2024-04-04 · Open, Classified
Recall details
- Recalling firm
- Navinetics Inc
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- HAW
- Quantity affected
- 20 kits
- Distribution
- US Nationwide distribution in the states of FL, MN, CO.
- Date initiated
- 2024-02-26
- Date posted
- 2024-04-04
- Location
- Rochester, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NaviNetics Reusable Stereotactic System (NN1000) (K231392) | Navinetics, Inc. | 2023-07-14 |