Medtronic NavLock Tracker Recalled Due to Incorrect Assembly
Medtronic Navigation is recalling one unit of the NavLock Tracker because incorrect assembly could affect navigation accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (navigation accuracy) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Medtronic Navigation, Inc. is recalling one unit of the NavLock Tracker (Product Number 9736061, Serial Number 000012585). The recall is classified as Class II by the U.S. Food and Drug Administration.
The product was incorrectly assembled, which could affect the navigation accuracy of the device. The affected unit was distributed in New York, United States.
Users should stop using the device and contact Medtronic Navigation for instructions on return or replacement.
The recalled product
- Product
- NavLock Tracker *** Rx Only
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 1
Distribution
Distributed in 1 state:
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