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U.S. Department of Health and Human Services

Class 2 Device Recall Nexframe Stereotactic

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  Class 2 Device Recall Nexframe Stereotactic see related information
Date Initiated by Firm October 04, 2007
Date Posted February 07, 2008
Recall Status1 Terminated 3 on July 13, 2012
Recall Number Z-0849-2008
Recall Event ID 45912
510(K)Number K012366  K022100  K043091  K040334  
Product Classification Stereotaxic instrument - Product Code HAW
Product Nexframe¿ Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041,
DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST,
DB-1043, DB-1043-BL, DB-1043-ST, DB-2031, DB-2040-BL,
DB-2040-ST, DB-2041, DB-2041-BL, DB-2041-ST, DB-2042,
DB-2042-BL, DB-2042-ST, DB-2043, DB-2043-BL, DB-2043-ST,, Medtronic, Inc, Minneapolis, Minnesota
Code Information Lot #s: 070380, 061248, 070175, 070375, 070621, 070825, 070634, 6510106A, 046510106A, 46515606, 046520506A, 046521606A, 046523406A,  61262, 70160, 070326, 070171, 60215, 070719, 070378, 070169, 070320, 70543, 070172, 610127, 610133, 70169, 61208, 70313, 51067, 60174, 60215 60578, 046510106C, 70153, 60175, 046510106F, 46534905, 046520506B, 070164, 070633, 070376, 070375, 070538, 070724, 070376, 61264, 61212,  070855, 070854, 070830, 070863, 070726, 070628, 60542, 60573, 60574, 60659, 61262, 70312, 070379, 61216, 70312, 070628, 070726, 61264, 070723 070166, 070629, 070164, 070379, 070856, 60583, 61237, 61238, 606110, 70312, 070159, 70174, 70144, 070160, 70375, 070631, 070825, 070726, 070628, 070863, 61208, 70145, 610134, 70321, 61247, 70315, 70334, 070724 070720, 070602, 070326, 070602, 070631, 070325, 070719, 70123, 70160,  046502607B, 070165, 070826, 046505707B, 60434, 60433, 046510106E 
Recalling Firm/
Manufacturer		 Medtronic Image Guided Neurologics, Inc.
2290 W Eau Gallie Blvd
Melbourne FL 32935-3133
For Additional Information Contact
321-757-8990 Ext. 210
Manufacturer Reason
for Recall		 Sterilty (package integrity) Compromised: Some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. The seal between the inner tray and lid has not been compromised and the contents remain sterile, however, the sterility of the outer surfaces of the inner tray and lid cannot be assured.
FDA Determined
Cause 2		 Package design/selection
Action On 10/4/2007, consignees were notified by Medtronic field personnel, either by personal visits or telephone. All wholesalers of this product are OUS. Medtronic OUS Regulatory personnel communicated this issue directly to the wholesalers, who provided the letters to their customers. Medtronic field personnel are responsible for completing and returning reply cards confirming all notifications (100%).
Quantity in Commerce 385
Distribution Worldwide, USA, Taiwan, Thailand, Japan, Spain, Sweden and The Netherlands.
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 = IMAGE-GUIDED NEUROLOGICS, INC.
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