Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off… recallZ-0125-2008 · Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK · initiated Sep 10, 2007
Terminated All recalls posted in February 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0125-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 10, 2007
- Posted by the FDA
- Feb 7, 2008
- Recalling firm
- Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
- Quantity
- 2,569
- Product code
- KWP
- FDA submissions
- K991031
- Distribution
- Worldwide Distribution - USA, Australia, Hong Kong and the Netherlands.
Product description
Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.
Code information (models, lots, serial numbers)
Lot Numbers: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809, and W07H1810.
Other devices under the same FDA submission
1 device cleared under K991031 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- COLORADO 2™ Spinal System 8638535Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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