Z-1613-2008

Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part...

Name: Z-1613-2008 Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part...
Creator: Med Tec Inc dba CIVCO Medical Solutions
Published: 2008-02-28
License: https://open.fda.gov/license/

Medtec LLC / initiated 2008-02-28 / Terminated / root cause: labeling and UDI

FDA source

Med Tec Inc dba CIVCO Medical Solutions began a recall of Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, CIVCO Medical Solutions... on 2008-02-28. The reason FDA records is "Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1613-2008
Status: Terminated
Initiated: 2008-02-28
Posted: 2008-05-21
Terminated: 2008-07-02
Recalling firm: Medtec LLC
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Lot Number: 080117-01

Product code IYE

K071614Class IIFiducial MarkersCivco / cleared 2007-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)