Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901000, 10mm, 5.5mm dia x 100mm, size: 10mm x 100mm, for spinal fixation. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901000, 10mm, 5.5mm dia x 100mm, size: 10mm x 100mm, for spinal fixation.
Brand
Medtronic Sofamor Danek USA Inc
Lot Codes / Batch Numbers
ALL LOTS
Products Sold
ALL LOTS
Medtronic Sofamor Danek USA Inc is recalling Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 790100 due to Breaks: Shear failure of the cable component of the system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Breaks: Shear failure of the cable component of the system.
Recommended Action
Per FDA guidance
Medtronic Sofamor Danek initiated its recall on 12/12/2007 by letter to all Risk Managers who received the product at their hospital. Letter were also mailed to surgeons who have implanted the product. Sales Representatives were notified via a conference call and letter to follow-up with thier respective surgeons who have implanted the product to verify that their surgeon received the communication of the recall and that they are aware that patient monitoring is recommended.
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