Z-0654-2007

Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA...

Name: Z-0654-2007 Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2007-02-02
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2007-02-02 / Terminated

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA, Rx only on 2007-02-02. The reason FDA records is "Bone screws may pull though the plate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0654-2007
Status: Terminated
Initiated: 2007-02-02
Posted: 2007-03-27
Terminated: 2007-08-11
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA, Rx only
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Bone screws may pull though the plate.
FDA root cause: Other
Action: Medtronic Global Quality initiated the recall via letter on 02/02/2007. Sub-recalls will be managed by Medtronic EMEA quality (Europe, Middle East, and Africa) in the affected geographies. Distributors and surgical facilities will be contacted as well as regulatory bodies in each country.
Quantity in commerce: 293 units
Distribution: France, Germany, Italy, UK, and Tunisia. No US distribution.
Product codes and lots: Lot Nos.: W04E0149, W04C1938, 553880, 672660, 353150, 355610, 201190, 198840, 947250, 914870, 82549, 81749, 81320, 76967, 65867, 42841, 42842.

Product code KWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)