—#68092

Product

Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881500, 15mm, 5.5mm dia x 100mm, size: 15mm x 100mm, not for distribution in the U.S.A. or its territories, for spinal fixation.

FDA product code: NQP — Posterior Metal/Polymer Spinal System, Fusion
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060615
Affected lot / code info: ALL CODES

Why it was recalled

Breaks: Shear failure of the cable component of the system.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Place, Memphis, Tennessee 38132-1719

Distribution

Distribution pattern: Worldwide Distribution: USA, Canada, India, Venezuela, Netherlands, Chile, Brazil, and Australia.

Timeline

Recall initiated: 2007-11-12
Posted by FDA: 2008-09-11
Terminated: 2010-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68092. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.