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U.S. Department of Health and Human Services

Class 2 Device Recall Left Long Tactile Probe

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  Class 2 Device Recall Left Long Tactile Probe see related information
Date Initiated by Firm February 06, 2012
Date Posted March 08, 2012
Recall Status1 Terminated 3 on March 26, 2012
Recall Number Z-1189-2012
Recall Event ID 61173
510(K)Number K990214  
Product Classification Neurological stereotaxic instrument - Product Code HAW
Product Left Long Tactile Probe, 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 Number 962009S: Lot Numbers 090106, 090407, 071219 
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.
826 Coal Creek Cir
Louisville CO 80027-9710
For Additional Information Contact
720-890-3200 Ext. 3303
Manufacturer Reason
for Recall		 When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra.
FDA Determined
Cause 2		 Device Design
Action An Urgent - Product Safety Notice customer letter was sent via FED EX on 2/6/12 and 2/6/12 to direct consignees in the US identifying the affected product and the issue with it. The letter states that Medtronic Navigation is removing the product from clinical use and will provide a sales credit to customers. In the letters to Medtronic field personnel, it states that local sales and service personnel will be identified to remove the affected product from customer sites and return them for scrapping. Customers are to contact a sales representative if they have any questions regarding the letter.
Quantity in Commerce 6 units
Distribution Worldwide Distribution -- US and Republic 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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