Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Mem
FDA device recall Z-0125-2008 · posted 2008-02-07 · Terminated
Recall details
- Recalling firm
- Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 2,569
- Distribution
- Worldwide Distribution - USA, Australia, Hong Kong and the Netherlands.
- Date initiated
- 2007-09-10
- Date posted
- 2008-02-07
- Date terminated
- 2009-07-14
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COLORADO II SPINAL SYSTEM (K991031) | Sofamor Danek USA,Inc. | 2000-05-10 |