Xtant Medical Holdings, Inc: Filler, Bone Void, Calcium Compound
Recall Summary XTANT Medical is recalling four types of nanOss 3D bone graft products because they were labeled with an incorrect shelf life of five years when the actual validated shelf life is four years. The affected products were distributed nationwide across the United States. This is a Class II recall, meaning the products could potentially cause serious adverse health consequences or death, though this recall specifically addresses the labeling discrepancy.
- Recalling firm
- XTANT Medical Holdings, Inc
- 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 Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc
- Reason
- Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-09
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/53f1c020-55b1-45a2-9ffe-2a63f3632da3