FDA recall, , Moderate risk
nanOss 3D Advanced Bone Graft Substitute
The bone graft substitutes were incorrectly labeled with a 5-year shelf life instead of the approved four years.
Summary by Recall Canary from the FDA notice
What happened
XTANT Medical Holdings, Inc., of Belgrade, Montana, recalled nanOss 3D Advanced Bone Graft Substitute and nanOss 3D Plus Advanced Bone Graft Substitute products because they were incorrectly labeled with a 5-year shelf life, while the approved and validated shelf life is four years. The recall began March 9, 2026, and was added to the FDA's Enforcement Report on April 21, 2026. The products were distributed nationwide in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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
- UDI-DI
- 00849777012478
- 00849777012492
- 00849777012461
- 00849777012539
- Lot code
- 385486-RP25-0080
- 387070-RP25-0081
- 415971-RP25-0077
- 436563-RP25-0082
- 436564-RP25-0079
- 436565-RP25-0076
- 444927-RP25-0078
- 387071-RP25-0083
- 418098-RP25-0084
- 436199-RP25-0085
- 401347-RP25-0070
- 415871-RP25-0073
- 415872-RP25-0074
- 416678-RP25-0072
- 416679-RP25-0071
- 418509-RP25-0075
- 445442-RP25-0128
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.
- Company
- XTANT Medical Holdings, IncBelgrade, Montana
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98643
- Recall number
- Z-1897-2026
All recalls from XTANT Medical Holdings, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
