Reported Apr 10, 2024 · Ongoing
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Navinetics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Navinetics Inc · 206 S Broadway Ste 700 · Rochester, MN · 55904
Is this the product you have?
- NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
- Lot codes and dates
UDI/DI 10850023620276Lot Number 331401724
- Amount recalled
- 20 kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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