Skull Anchor Key Defect Prevents CT Localizer Attachment
Navinetics Inc. has recalled the NaviNetics Skull Anchor Key and Drill Kit (Lot 331401724) because the skull anchor key may fail to allow proper attachment of the CT localizer, preventing stereotactic imaging procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II risk-of-harm product (stereotactic surgical imaging anchor) where the device fails to function as intended (CT localizer cannot attach), but no injuries or illnesses have been reported. The device malfunction may prevent necessary medical imaging.
Plain-English summary
Navinetics Inc. is recalling the NaviNetics Skull Anchor Key and Drill Kit, model REF NN1215, used in stereotactic imaging procedures. The recall was issued by the U.S. Food and Drug Administration on medical device recall Z-1478-2024. A total of 20 kits were distributed nationwide to medical facilities in Florida, Minnesota, and Colorado.
The skull anchor key is a single-use device that is attached to the patient before imaging. Once attached, the CT localizer must be secured by screwing four thumbscrews into threaded holes on the anchor key's top surface. The defect prevents proper attachment of the CT localizer, which is necessary to perform stereotactic imaging.
Healthcare providers and patients affected by this recall should discontinue use of the recalled product and contact Navinetics Inc. immediately. If the skull anchor key has already been implanted, consult with your medical team regarding next steps.
The recalled product
- Product
- NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
- Manufacturer
- Navinetics Inc
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10850023620276
- Lot Number 331401724
Distribution
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