Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881020, 10mm, 5.5mm dia x 120mm, size: 10mm x 120mm, for spinal fixation, not for distribution in the U.S.A. or its territories.
FDA Recall Z-1427-2008 · Posted 2008-09-11
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Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeNQP
Date Initiated2007-11-12
Date Terminated2010-08-10
Product Quantity54 units
Reason for Recall
Breaks: Shear failure of the cable component of the system.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: USA, Canada, India, Venezuela, Netherlands, Chile, Brazil, and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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