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All product recalls associated with NuVasive Specialized Orthopedics, Inc..
Total Recalls
11
Past Year
0
Class I (Serious)
0
Most Recent
Sep 2024
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.
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.
The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.