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All product recalls associated with Medtronic Sofamor Danek USA Inc.
Total Recalls
1000
Past Year
1000
Class I (Serious)
143
Most Recent
Jan 2026
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.
The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.
Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. The failure only affects the electrical portion of the switch. If the clinician does not intervene, the patient could experience hypoventilation leading to h