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Recall

NavLock Tracker *** Rx Only

Medtronic Navigation, Inc. · 28 Aug 2019

Status
Recall terminated
Why, in the FDA's words
“Product was incorrectly assembled which could affect navigation accuracy of the device.”
Recall began
28 Aug 2019
Company
Medtronic Navigation, Inc.
Device type
Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
Concerns
K171267, K182104

What it means

A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.

The record

The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.
FDA database