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.
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. Quantity: 20 kits Lot/code info: UDI/DI 10850023620276, Lot Number 331401724
10850023620276
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.