Navinetics recalls Skull Anchor Key and Drill Kit REF NN121: Defective key prevents CT Localizer attachment during stereotactic imaging procedures. Affected units have specific serial numbers and lot numbers.
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.
Navinetics is recalling a Skull Anchor Key and Drill Kit (REF NN1215) because the key may not attach the CT Localizer properly during stereotactic imaging. This could prevent critical medical procedures from being completed safely.
The defective Skull Anchor Key may not securely attach the CT Localizer after being placed on the patient. This prevents the necessary steps for stereotactic imaging, which is a precise medical procedure for targeting treatments like radiation therapy.
Medical professionals using this device for stereotactic imaging procedures are most at risk. Patients undergoing these procedures may be affected if the device fails to function correctly.
Check for the product name 'NaviNetics Skull Anchor Key and Drill Kit' with reference number NN1215. Affected units have UDI/DI 10850023620276 and lot number 331401724.
Verify the reference number NN1215 and UDI/DI 10850023620276 on the product label.
The Skull Anchor Key may not attach the CT Localizer properly during stereotactic imaging procedures, preventing critical medical steps from being completed safely.
The recall record does not specify a remedy, so check the product details to confirm if it's affected and contact Navinetics for further instructions.
Affected units have reference number NN1215, UDI/DI 10850023620276, and lot number 331401724.
We’ve drafted a message you can send Navinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-1478-2024 — Navinetics Navinetics Hello, I own a Navinetics that is covered by recall Z-1478-2024 from Navinetics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
