Date Initiated by Firm |
January 20, 2011 |
Date Posted |
October 03, 2011 |
Recall Status1 |
Terminated 3 on October 03, 2011 |
Recall Number |
Z-0001-2012 |
Recall Event ID |
57858 |
510(K)Number |
K990214
|
Product Classification |
Neurological Stereotaxic Instrument - Product Code HAW
|
Product |
Probe, Tactile, Left, ASM, Long, Part #962009S, 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 |
Part #962009S. Lot Number 090106. |
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
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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.
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510(K) Database |
510(K)s with Product Code = HAW and Original Applicant = SURGICAL NAVIGATION TECHNOLOGIES, INC.
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