Medical device recalls Moderate risk

Medtronic Navigation, Inc. recalls NavLock Tracker *** Rx Only

Recall date
August 28, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1693-2020
FDA classification
Class II
Brand / firm
Medtronic Navigation, Inc.
Sold / distributed
U.S.: NY No O.U.S.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NavLock Tracker *** Rx Only

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