Med Tec Inc dba CIVCO Medical Solutions 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Med Tec Inc dba CIVCO Medical Solutions
Lot Codes / Batch Numbers
Lot Number: 080117-01
Products Sold
Lot Number: 080117-01
Med Tec Inc dba CIVCO Medical Solutions is recalling Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; due to Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026