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All product recalls associated with Medtronic Sofamor Danek USA Inc.
Total Recalls
59
Past Year
1
Class I (Serious)
0
Most Recent
Sep 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Breaks: Shear failure of the cable component of the system.
Surgical manual/technique lack information required as a condition of the 510(k) approval.
Labeling, including indications for use, lack 510 (K) approval