Date Initiated by Firm |
October 31, 2003 |
Date Posted |
December 17, 2003 |
Recall Status1 |
Terminated 3 on December 19, 2003 |
Recall Number |
Z-0231-04 |
Recall Event ID |
27734 |
510(K)Number |
K001153 K021980 K012937 K030552
|
Product Classification |
Neurological Stereotaxic Instrument - Product Code HAW
|
Product |
Fix pins associated with Stealth Station Treatment Guidance Platform |
Code Information |
3'' fix pin - 9730476, Lot numbers 200302130552, 200302140566 and 200302260619. 5'' fix pin - 9730477, Lot numbers200302140564, and 200303030641. |
Recalling Firm/ Manufacturer |
Medtronic Surgical Navigation Tech, Inc 826 Coal Creek Cir Louisville CO 80027-9710
|
For Additional Information Contact |
720-890 Ext. 3200
|
Manufacturer Reason for Recall |
Surgical devices intended for single use were not labeled for single use.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter on 11/01/2003. |
Quantity in Commerce |
127 devices |
Distribution |
Domestic distribution to CA,FL,GA,KS,TX. Foreign distribution to Belgium, France, Germany, Hong Kong, Japan. No military or government consignees. |
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 = MEDTRONIC SURGICAL NAVIGATION 510(K)s with Product Code = HAW and Original Applicant = MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
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