NavLock Tracker *** Rx Only
This recall has been terminated (originally issued April 10, 2020).
- Company
- Medtronic Navigation, Inc.
- Recall Initiated
- August 28, 2019
- Posted
- April 10, 2020
- Terminated
- May 5, 2021
- Recall Number
- Z-1693-2020
- Quantity
- 1 unit
- Firm Location
- Louisville, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Product was incorrectly assembled which could affect navigation accuracy of the device.
Distribution
U.S.: NY No O.U.S.
Lot / Code Info
Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585
Root Cause
Employee error
Action Taken
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.