Date Initiated by Firm | February 06, 2012 |
Date Posted | March 08, 2012 |
Recall Status1 |
Terminated 3 on March 26, 2012 |
Recall Number | Z-1190-2012 |
Recall Event ID |
61173 |
510(K)Number | K990214 |
Product Classification |
Neurological stereotaxic instrument - Product Code HAW
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Product | Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027.
Trackable handheld 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 962011S: Lot Numbers 090106, 071219 |
Recalling Firm/ Manufacturer |
Medtronic Navigation, Inc. 826 Coal Creek Cir Louisville CO 80027-9710
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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 | 5 units |
Distribution | Worldwide Distribution -- US and Republic 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
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