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U.S. Department of Health and Human Services

Class 2 Device Recall UPGRD PRGM 9734638 ADD AxiEM NAVIGATION

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 Class 2 Device Recall UPGRD PRGM 9734638 ADD AxiEM NAVIGATIONsee related information
Date Initiated by FirmApril 24, 2014
Date PostedMay 09, 2014
Recall Status1 Terminated 3 on December 29, 2014
Recall NumberZ-1602-2014
Recall Event ID 68145
510(K)NumberK001284 K012937 K022074 K033621 K871247 K990214 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductUPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Code Information Lot No.: 6148186
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information ContactMichael 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
ActionDomestic 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 Commerce26,674 total
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(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
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