nanOss 3D Bone Graft Substitute Incorrectly Labeled with Five-Year Shelf Life
XTANT Medical Holdings is recalling nanOss 3D Advanced Bone Graft Substitute products due to incorrect labeling showing a 5-year shelf life when the approved shelf life is four years.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error (incorrect shelf-life duration) with no reported illnesses or injuries. Labeling errors that are precautionary in nature and do not involve high-risk contamination or allergen mislabeling typically fall into the Moderate category.
Plain-English summary
XTANT Medical Holdings, Inc. is recalling nanOss 3D Advanced Bone Graft Substitute and nanOss 3D Plus Advanced Bone Graft Substitute products. The products were incorrectly labeled with a 5-year shelf life when the approved and validated shelf life is four years.
Affected products include multiple part numbers and lot numbers distributed nationwide in California, Connecticut, District of Columbia, Kansas, Maryland, North Carolina, New York, Texas, and Wisconsin. A total of 225 units are subject to this recall.
Consumers and healthcare facilities in possession of affected products should discontinue use and contact XTANT Medical Holdings, Inc. for instructions on product return or replacement. The incorrect shelf-life label may result in use of product beyond its validated storage period.
The recalled product
- Product
- nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Gr
- Manufacturer
- XTANT Medical Holdings, Inc
- Hazard
- shelf-life-mislabeling
Distribution
Distributed nationwide across the United States.
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