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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.
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Nonconforming product; length of the product measured shorter than the labeled length.
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.