Recall Z-1007-2017— Medtronic Navigation, Inc.

Name: FDA recall Z-1007-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-12

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2016-12-12, terminated 2017-05-19. It names one FDA 510(k) clearance: K141833. Product: 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: 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.
Classification: Class II
Status: Terminated
Initiated: 2016-12-12
Terminated: 2017-05-19
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K141833 — STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATIONMedtronic Navigation, Inc.·cleared 2015-03-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.