NavLock recallZ-1693-2020 · Medtronic Navigation, Inc. · initiated Aug 28, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Navigation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product was incorrectly assembled which could affect navigation accuracy of the device.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1693-2020
- Status
- Terminated
- Initiated by the company
- Aug 28, 2019
- Posted by the FDA
- Apr 10, 2020
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 1 unit
- Product code
- OLO
- FDA submissions
- K171267, K182104
- Distribution
- U.S.: NY No O.U.S.
Product description
NavLock Tracker *** Rx Only
Code information (models, lots, serial numbers)
Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NavLock 9736061Medtronic Navigation, Inc. · Orthopedic stereotaxic instrument1 recall8 reports
Product lines
Other devices under the same FDA submission
6 devices cleared under K171267, K182104 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NavLock 9736060Medtronic Navigation, Inc. · Orthopedic stereotaxic instrument11 reports
- N/A 9734682Medtronic Navigation, Inc. · Orthopedic stereotaxic instrument9 reports
- N/A 9734683Medtronic Navigation, Inc. · Orthopedic stereotaxic instrument8 reports
- NA 9734683Medtronic Navigation, Inc. · Orthopedic stereotaxic instrument4 reports
- NA 9734590Medtronic Navigation, Inc. · Orthopedic stereotaxic instrument3 reports
- NA 9734734Medtronic Navigation, Inc. · Orthopedic stereotaxic instrument2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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