Rochester, MN, United States
Navinetics Inc recalls
1 recall recorded since 2018, most recently on 26 February 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 February 2024
- 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.
- Distribution
- US Nationwide distribution in the states of FL, MN, CO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1478-2024
- NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.