AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a ...
FDA Recall #Z-1007-2017 — Class II — December 12, 2016
Product Description
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
Reason for Recall
Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the StealthStation¿ System with Touch N Go Pointer Probes for patient registration.
Recalling Firm
Medtronic Navigation, Inc. — Louisville, CO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
111 devices
Distribution
US Nationwide Distribution.
Code Information
lot number 150626B
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated