FDAClass IIApril 22, 2020

NavLock Tracker *** recall

NavLock Tracker *** Rx Only

Why was NavLock Tracker *** recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585

Product
NavLock Tracker *** Rx Only
Recalling firm
Medtronic Navigation, Inc.
Quantity
1 unit
Distribution
U.S.: NY No O.U.S.
Recall date
April 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls