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U.S. Department of Health and Human Services

Class 2 Device Recall Right Long Tactile Probe

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  Class 2 Device Recall Right Long Tactile Probe see related information
Date Initiated by Firm January 20, 2011
Date Posted October 03, 2011
Recall Status1 Terminated 3 on October 03, 2011
Recall Number Z-0002-2012
Recall Event ID 57858
510(K)Number K990214  
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
Product Probe, Tactile, Right, ASM, Long,
Part #962011S,
Medtronic Navigation,
Louisville, CO 80027.

Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Code Information Lot Number 071219
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc
826 Coal Creek Circle
Louisville CO 80027-9710
For Additional Information Contact
720-890-3409
Manufacturer Reason
for Recall		 Distal end of tactile probe may break off during use.
FDA Determined
Cause 2		 Labeling design
Action Medtronic sent an "Urgent Product Safety Notice" to all affected customers dated Jan 20, 2011. The letter included affected product and updated instructions for use. On-site training was given for the use of the probes by Medtronic Representatives. For information on this recall call Medtronics at (720) 890-3409.
Quantity in Commerce 6 probes
Distribution Worldwide Distribution: Nationwide distribution including the states of CO and WI; and the country of South Korea
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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