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Class 3 Device Recall Fiducial Markers, Sterile (2mm spheres) Bone gold markers |
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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
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Product Classification |
Medical charged-particle radiation therapy system - Product Code IYE
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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
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For Additional Information Contact |
James Leong 319-656-4447 Ext. 224
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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.
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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
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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 = IYE and Original Applicant = CIVCO
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