Date Initiated by Firm |
December 12, 2016 |
Date Posted |
January 11, 2017 |
Recall Status1 |
Terminated 3 on May 19, 2017 |
Recall Number |
Z-1007-2017 |
Recall Event ID |
76060 |
510(K)Number |
K141833
|
Product Classification |
Neurological stereotaxic Instrument - Product Code HAW
|
Product |
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton. |
Code Information |
lot number 150626B |
Recalling Firm/ Manufacturer |
Medtronic Navigation, Inc. 826 Coal Creek Cir Louisville CO 80027-9710
|
For Additional Information Contact |
Scott Hutton 720-890-3302
|
Manufacturer Reason for Recall |
Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the StealthStation¿ System with Touch N Go Pointer Probes for patient registration.
|
FDA Determined Cause 2 |
Process change control |
Action |
The firm, Medtronic, sent an "URGENT: MEDICAL DEVICE RECALL" letter on 12/12/16 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for any affected products, quarantine them for return to Medtronic; complete and return the CUSTOMER RESPONSE FORM by email at RS.NavFCA@medtronic.com or fax to Medtronic Technical Services at 651-367-7075 (even if you do not have affected product); and contact Medtronic Technical Services at 1-800-595-9709 to get a return material authorization (RMA) and arrange for their return and no charge replacements.
If you have any questions regarding this communication, please contact Medtronic Technical Services at (800) 595-9709. |
Quantity in Commerce |
111 devices |
Distribution |
US Nationwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
|
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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 = HAW and Original Applicant = MEDTRONIC NAVIGATION, INC.
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