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/ Manufacturer |
Medtronic Navigation, Inc. 826 Coal Creek Cir Louisville CO 80027-9710
|
For Additional Information Contact |
Todd Hansell 720-890-3200
|
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
|