Date Initiated by Firm | April 24, 2014 |
Date Posted | May 09, 2014 |
Recall Status1 |
Terminated 3 on December 29, 2014 |
Recall Number | Z-1597-2014 |
Recall Event ID |
68145 |
510(K)Number | K001284 K012937 K022074 K033621 K871247 K990214 |
Product Classification |
Neurological stereotaxic Instrument - Product Code HAW
|
Product | TRAJ GUIDE KIT, 9733065, BIOPSY, EXT |
Code Information |
Lot No.: 0066225613 0066207713B 0066202413 0066212611 0066209012a 0066209012a |
Recalling Firm/ Manufacturer |
Medtronic Navigation, Inc. 826 Coal Creek Cir Louisville CO 80027-9710
|
For Additional Information Contact | Michael Blasco 720-890-3391 |
Manufacturer Reason for Recall | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Domestic Urgent Medical Device Safety Notice letters were shipped on April 24 and 25, 2014. The letters indicated that a Medtronic representative will contact the hospital and arrange for a visit to collect affected products and arrange for no charge replacements or credit. Questions regarding this recall should be directed to Medtronic Navigation Technical Services at 1-800-595-9709. |
Quantity in Commerce | 26,674 total |
Distribution | Nationwide Distribution |
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 = HAW 510(K)s with Product Code = HAW 510(K)s with Product Code = HAW 510(K)s with Product Code = HAW 510(K)s with Product Code = HAW
|