XTANT Medical Holdings, Inc. is recalling approximately 225 units of nanOss 3D and nanOss 3D Plus Advanced Bone Graft Substitutes because they were incorrectly labeled with a five-year shelf life. The products are only approved and validated for a four-year shelf life, meaning the product may not perform as expected if used in the fifth year. This recall affects various sizes and configurations used in surgical procedures, and no injuries or incidents have been reported to date. These medical devices were distributed to hospitals, surgical centers, and distributors in several U.S. states.
Using a bone graft substitute beyond its validated four-year shelf life may result in the product losing its structural integrity or biological effectiveness, potentially leading to surgical failure or the need for additional medical procedures. No injuries have been reported.
Incorrectly labeled with 5-year shelf life instead of 4-year.
Incorrectly labeled with 5-year shelf life instead of 4-year.
Incorrectly labeled with 5-year shelf life instead of 4-year.
Incorrectly labeled with 5-year shelf life instead of 4-year.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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