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All product recalls associated with Medtronic Sofamor Danek USA Inc.
Total Recalls
275
Past Year
5
Class I (Serious)
17
Most Recent
Dec 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.
Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.
Bone screws may pull though the plate.
Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use.