FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.: NavLock Tracker *** Rx Only
- Recall number
- Z-1693-2020
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- NavLock Tracker *** Rx Only
- Status
- Terminated
- Initiated
- 2019-08-28
- Posted
- 2020-04-10
- Terminated
- 2021-05-05
- Reason
- Product was incorrectly assembled which could affect navigation accuracy of the device.
- 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 RS.NavFCA@medtronic.com or fax it to Medtronic at 651-367-7075.
- Quantity
- 1 unit
- Distribution
- U.S.: NY No O.U.S.
- Lot, serial or model codes
- Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585
- 510(k) numbers
- ["K171267","K182104"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28