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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Passive Planar Blunt Probe

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  Class 2 Device Recall Medtronic Passive Planar Blunt Probe see related information
Date Initiated by Firm May 05, 2015
Date Posted June 12, 2015
Recall Status1 Terminated 3 on July 02, 2015
Recall Number Z-1794-2015
Recall Event ID 71278
510(K)Number K972398  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.
Code Information lot number 150223
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		 Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Medtronic sent an Medical Device Safety Alert letter dated May 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by the user: "Examine your inventory and if any of the affected products are found, please quarantine them for return to Medtronic. "A Medtronic representative will follow-up to arrange for removal and replacement. If you have any questions regarding this action, please contact Medtronic Navigation Technical Services at 1-800-595-9709.
Quantity in Commerce 18
Distribution US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.
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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