Recall Z-1693-2020— Medtronic Navigation, Inc.

Name: FDA recall Z-1693-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-28

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2019-08-28, terminated 2021-05-05. It names 2 FDA 510(k) clearances: K182104, K171267. Product: NavLock Tracker *** Rx Only. Reason: Product was incorrectly assembled which could affect navigation accuracy of the device..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-08-28
Terminated: 2021-05-05
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

2 on FDA's record

K182104 — NavLock Trackers, Robotic Reference FrameMedtronic Navigation·cleared 2018-11-02
K171267 — NavLock TrackersMedtronic Navigation·cleared 2017-07-03

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

NavLock Tracker *** Rx Only

Reason for recall

Product was incorrectly assembled which could affect navigation accuracy of the device.

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