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U.S. Department of Health and Human Services

Class 2 Device Recall NavLock Blue Tracker

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  Class 2 Device Recall NavLock Blue Tracker see related information
Date Initiated by Firm August 28, 2019
Date Posted April 10, 2020
Recall Status1 Terminated 3 on May 05, 2021
Recall Number Z-1693-2020
Recall Event ID 85318
510(K)Number K182104  K171267  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product NavLock Tracker *** Rx Only
Code Information Product Number: 9736061 UDI (GTIN/UPN): 00763000123185 Serial Number: 000012585
Recalling Firm/
Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Todd Hansell
Manufacturer Reason
for Recall
Product was incorrectly assembled which could affect navigation accuracy of the device.
FDA Determined
Cause 2
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 in Commerce 1 unit
Distribution U.S.: NY No O.U.S.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = Medtronic Navigation