Recall Z-1478-2024
Navinetics Inc · initiated February 26, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Codes / lots: UDI/DI 10850023620276, Lot Number 331401724
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1478-2024
- Initiated
- February 26, 2024
- Posted by FDA
- April 4, 2024
- Product code
- HAW – Neurological Stereotaxic Instrument
- Quantity
- 20 kits
- Distribution
- US Nationwide distribution in the states of FL, MN, CO.
- Recalling firm
- Navinetics Inc, Rochester, MN