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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Passive Biopsy Needle Kit

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  Class 2 Device Recall Medtronic Passive Biopsy Needle Kit see related information
Date Initiated by Firm July 17, 2015
Date Posted August 03, 2015
Recall Status1 Terminated 3 on April 07, 2016
Recall Number Z-2325-2015
Recall Event ID 71756
510(K)Number K971247  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit.
The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
Code Information LOT No: 0007525461. 0007599312 
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact Scott Hutton
720-890-3302
Manufacturer Reason
for Recall		 The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper placement of the needles biopsy window in the brain.
FDA Determined
Cause 2		 Process change control
Action Medtronic sent an Urgent Medical Device Recall letter dated July 17, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for any of the affected lots and quarantine them if found. They will be asked to complete a confirmation form indicating they have completed this action and are to email or fax the form to Medtronic. Customers will be asked to contact Medtronic to obtain a return material authorization number and arrange for no-charge replacements of impacted products. Customers with questions were instructed to contact Medtronic Technical Services at 800-595-9709. For questions regarding this recall call 720-890-3302.
Quantity in Commerce 1415 total
Distribution Worldwide Distribution - US (nationwide) and Canada.
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 and Original Applicant = SURGICAL NAVIGATION TECHNOLOGIES, INC.
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