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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.
Brand
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Lot Codes / Batch Numbers
Lot Numbers: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809, and W07H1810.
Products Sold
Lot Numbers: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809, and W07H1810.
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK is recalling Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 863 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026