Z-1693-2020Class II

NavLock Tracker *** Rx Only

Name: Z-1693-2020 NavLock Tracker *** Rx Only
Creator: Medtronic Navigation, Inc.
Published: 2019-08-28
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2019-08-28 / Terminated / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of NavLock Tracker *** Rx Only on 2019-08-28. FDA classified it as Class II and gives the reason as "Product was incorrectly assembled which could affect navigation accuracy of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1693-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-28
Posted: 2020-04-10
Terminated: 2021-05-05
Recalling firm: Medtronic Navigation, Inc
Product: NavLock Tracker *** Rx Only
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Product was incorrectly assembled which could affect navigation accuracy of the device.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 08/28/2019, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification to its customer informing them of the manufacturing issue (incorrect assembly) and instructed them to: 1. Examine their inventory, and immediately quarantine the affected NavLock" Tracker and to return to the Recalling Firm. 2. To contact the Recalling Firm at 1-888-826-5603 to receive a return material authorization (RMA) and to arrange for return and a no-charge replacement. Once an RMA number is obtained, ship the affected product to Medtronic Product Services, 1480 Arthur Ave, Louisville CO 80027. 3. Follow instructions on the attached Customer Confirmation Form. Sign and date the bottom of the form and then return the form to [email protected] or fax it to Medtronic at 651-367-7075.
Quantity in commerce: 1 unit
Distribution: U.S.: NY No O.U.S.
Product codes and lots: Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1693-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1693-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-22	2020-04-10

Product code OLO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)