NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
This recall is currently active, issued April 4, 2024. It was issued by Navinetics Inc.
- Company
- Navinetics Inc
- Recall Initiated
- February 26, 2024
- Posted
- April 4, 2024
- Recall Number
- Z-1478-2024
- Quantity
- 20 kits
- Firm Location
- Rochester, MN
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of FL, MN, CO.
Lot / Code Info
UDI/DI 10850023620276, Lot Number 331401724
Root 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.