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U.S. Department of Health and Human Services

Class 3 Device Recall Fiducial Markers, Sterile (2mm spheres) Bone gold markers

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  Class 3 Device Recall Fiducial Markers, Sterile (2mm spheres) Bone gold markers see related information
Date Initiated by Firm February 28, 2008
Date Posted May 21, 2008
Recall Status1 Terminated 3 on July 02, 2008
Recall Number Z-1613-2008
Recall Event ID 46905
510(K)Number K071614  
Product Classification Medical charged-particle radiation therapy system - Product Code IYE
Product Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.
Code Information Lot Number: 080117-01
Recalling Firm/
Manufacturer		 Med Tec Inc dba CIVCO Medical Solutions
1401 8th St
PO Box 320
Orange City IA 51041-0320
For Additional Information Contact James Leong
319-656-4447 Ext. 224
Manufacturer Reason
for Recall		 Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers.
FDA Determined
Cause 2		 Labeling mix-ups
Action Consignees were notified via telephone beginning 2/28/08 and a Recall Notification letter sent on 2/29/08. Users were requested to return any affected products for a replacement. They were also requested to return a recall notification form indicating the amount of affected product in their inventory. For additional information, call 800-842-8688.
Quantity in Commerce 36/3-marker pouches
Distribution Nationwide Distribution including states of WA, PA, DE, AL, CT, WI, FL, TX, MN, and IL.
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 = IYE and Original Applicant = CIVCO
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