FDA Medical Device Recalls (openFDA)
Navinetics Inc: NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
- Recall number
- Z-1478-2024
- Recalling firm
- Navinetics Inc
- Product
- NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
- Status
- Open, Classified
- Initiated
- 2024-02-26
- Posted
- 2024-04-04
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI/DI 10850023620276, Lot Number 331401724
- 510(k) numbers
- ["K231392"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 3023194190
- Firm city
- Rochester
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28