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U.S. Department of Health and Human Services

Class 2 Device Recall Treatment Guidance Platform

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 Class 2 Device Recall Treatment Guidance Platformsee related information
Date Initiated by FirmOctober 31, 2003
Date PostedDecember 17, 2003
Recall Status1 Terminated 3 on December 19, 2003
Recall NumberZ-0231-04
Recall Event ID 27734
510(K)NumberK001153 K012937 K021980 K030552 
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
ProductFix pins associated with Stealth Station Treatment Guidance Platform
Code Information 3'' fix pin - 9730476, Lot numbers 200302130552, 200302140566 and 200302260619.  5'' fix pin - 9730477, Lot numbers200302140564, and 200303030641.
FEI Number 1000517638
Recalling Firm/
Manufacturer		 Medtronic Surgical Navigation Tech, Inc
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact
720-890 Ext. 3200
Manufacturer Reason
for Recall		Surgical devices intended for single use were not labeled for single use.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter on 11/01/2003.
Quantity in Commerce127 devices
DistributionDomestic distribution to CA,FL,GA,KS,TX. Foreign distribution to Belgium, France, Germany, Hong Kong, Japan. No military or government consignees.
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
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