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U.S. Department of Health and Human Services

Class 2 Device Recall SPHERES 8801075 5/TRAY 12PK

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 Class 2 Device Recall SPHERES 8801075 5/TRAY 12PKsee related information
Date Initiated by FirmApril 24, 2014
Date PostedMay 09, 2014
Recall Status1 Terminated 3 on December 29, 2014
Recall NumberZ-1596-2014
Recall Event ID 68145
510(K)NumberK001284 K012937 K022074 K033621 K871247 K990214 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductSPHERES 8801075 5/TRAY 12PK
Code Information Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121 
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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