FDA Recall
Open, Classified
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Recall: Z-1478-2024
·
Initiated February 26, 2024
Recall
- Recall Number
- Z-1478-2024
- Event Number
- 94163
- Firm
- Navinetics Inc
- FEI Number
- 3023194190
- Product Code
- HAW
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- February 26, 2024
- Posted
- April 4, 2024
- Address
- 206 S Broadway, Ste 700, Rochester, MN, 55904
Description
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
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.
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.
Distribution
US Nationwide distribution in the states of FL, MN, CO.
Quantity
20 kits