FDA Medical Device Recalls (openFDA)
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK: Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.
- Recall number
- Z-0125-2008
- Recalling firm
- Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
- Product
- Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.
- Status
- Terminated
- Initiated
- 2007-09-10
- Posted
- 2008-02-07
- Terminated
- 2009-07-14
- Reason
- 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
- 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
- 2,569
- Distribution
- Worldwide Distribution - USA, Australia, Hong Kong and the Netherlands.
- Lot, serial or model codes
- Lot Numbers: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809, and W07H1810.
- 510(k) numbers
- ["K991031"]
- PMA numbers
- not on file
- Product code
- KWP
- Firm FEI
- 1824199
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28