CLASS II Device recall · Reported 22 Apr 2020 · FDA Enforcement Report

NavLock Tracker *** recalled by Medtronic Navigation

Medtronic Navigation is recalling NavLock Tracker ***, distributed in New York. The recall was initiated on 28 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585

Quantity recalled1 unit

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1693-2020
FDA event ID: 85318
Recalling firm: Medtronic Navigation, Louisville, CO
Classification: Class II
Status: Terminated
Recall initiated: 28 Aug 2019
FDA classified: 10 Apr 2020
Reported: 22 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Aug 2019	Recall initiated by company
10 Apr 2020	Classified by FDA	+226 days
22 Apr 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

NavLock Tracker *** Rx Only

Where it was distributed

U.S.: NY No O.U.S.

New York

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

U.S.: NY No O.U.S.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medtronic Navigation

All 92

Reported	Class	Recall	Company	Reason	Where
5 Feb 2025Device	CLASS II	Medtronic Pin Sterile Percutaneous recalled by Medtronic Navigation	Medtronic Navigation	Other	Nationwide
16 Oct 2024Device	CLASS II	StealthStation S8 App versions 1.3.0 and 1.3.2 recalled	Medtronic Navigation	Device Malfunction	Nationwide
15 May 2024Device	CLASS I	Stealth S8 Clinical recalled by Medtronic Navigation	Medtronic Navigation	Device Malfunction	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733236, Pin, 150mm, Sterile, Percutaneous recalled	Medtronic Navigation	Other	Nationwide
17 Jan 2024Device	CLASS II	Medtronic, REF 9733235, Pin, 100mm, Sterile, Percutaneous recalled	Medtronic Navigation	Other	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide