Z-0125-2008

Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111...

Name: Z-0125-2008 Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111...
Creator: Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Published: 2007-09-10
License: https://open.fda.gov/license/

Warsaw Orthopedic, Inc. / initiated 2007-09-10 / Terminated / root cause: manufacturing process

FDA source

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK began a recall of Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138 on 2007-09-10. The reason FDA records is "Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0125-2008
Status: Terminated
Initiated: 2007-09-10
Posted: 2008-02-07
Terminated: 2009-07-14
Recalling firm: Warsaw Orthopedic, Inc.
Product: Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic Sofamor Danek notified consignees by Urgent Device Recall letter dated 9/10/07 to immediately cease using the product and to return the devices with a Product Recall Questionnaire, recording quantity of devices and any patient injuries.
Quantity in commerce: 2,569
Distribution: Worldwide Distribution - USA, Australia, Hong Kong and the Netherlands.
Product codes and lots: Lot Numbers: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809, and W07H1810.

Product code KWP

K991031Class IIColorado II Spinal SystemSofamor Danek USA,Inc. / cleared 2000-05-10

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)