Medtronic Navigation, Inc. NavLock Tracker *** Rx Only Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NavLock Tracker *** Rx Only
Brand
Medtronic Navigation, Inc.
Lot Codes / Batch Numbers
Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585
Products Sold
Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585
Medtronic Navigation, Inc. is recalling NavLock Tracker *** Rx Only due to Product was incorrectly assembled which could affect navigation accuracy of the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was incorrectly assembled which could affect navigation accuracy of the device.
Recommended Action
Per FDA guidance
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 RS.NavFCA@medtronic.com or fax it to Medtronic at 651-367-7075.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NY
Page updated: Jan 10, 2026