Date Initiated by Firm |
April 24, 2014 |
Date Posted |
May 09, 2014 |
Recall Status1 |
Terminated 3 on December 29, 2014 |
Recall Number |
Z-1586-2014 |
Recall Event ID |
68145 |
510(K)Number |
K871247 K990214 K001284 K012937 K022074 K033621
|
Product Classification |
Neurological stereotaxic Instrument - Product Code HAW
|
Product |
INSTRUMENT TRACKER 9733533XOM ENT 1PK |
Code Information |
Lot No.: 130904C 131203A 131003 131024B 130815 130904C 130510 130815 130708B 130815 130815 130716D 130204C 130418B 121128C 121218B 121218A 121128D 130409C 130409D 130123 |
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
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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 = I.Z.I. CORP. 510(K)s with Product Code = HAW and Original Applicant = KRONNER MEDICAL 510(K)s with Product Code = HAW and Original Applicant = MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 510(K)s with Product Code = HAW and Original Applicant = NORTHERN DIGITAL, INC. 510(K)s with Product Code = HAW and Original Applicant = SURGICAL NAVIGATION TECHNOLOGIES, INC.
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