Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Nexframe Stereotactic

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Nexframe Stereotacticsee related information
Date Initiated by FirmOctober 04, 2007
Date PostedFebruary 07, 2008
Recall Status1 Terminated 3 on July 13, 2012
Recall NumberZ-0849-2008
Recall Event ID 45912
510(K)NumberK012366 K022100 K040334 K043091 
Product Classification Stereotaxic instrument - Product Code HAW
ProductNexframe 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 
FEI Number 3002684500
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
ActionOn 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 Commerce385
DistributionWorldwide, USA, Taiwan, Thailand, Japan, Spain, Sweden and The Netherlands.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HAW
-
-