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Terminated

Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.

FDA Recall Z-0125-2008 · Posted 2008-02-07

Recalling FirmWarsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Recall StatusTerminated
Product CodeKWP
Date Initiated2007-09-10
Date Terminated2009-07-14
Product Quantity2,569

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - USA, Australia, Hong Kong and the Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991031COLORADO II SPINAL SYSTEMSofamor Danek USA,Inc. · 2000-05-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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