nanOss 3D Advanced Bone Graft Substitute recallZ-1897-2026 · XTANT Medical Holdings, Inc · initiated Mar 9, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from XTANT Medical Holdings, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
FDA root cause category: Incorrect or no expiration date
What the company is doing
On March 9, 2026, the firm began notifying customers via letters titled "URGENT: MEDICAL DEVICE RECALL." Customers were instructed to segregate and quarantine all affected products to prevent use, and discontinue use of any affected product. Affected product must be returned to Xtant Medical.
Recall details
- Recall number
- Z-1897-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 9, 2026
- Posted by the FDA
- Apr 21, 2026
- Recalling firm
- XTANT Medical Holdings, Inc
- Quantity
- 225
- Product code
- MQV
- FDA submissions
- K132050
- Distribution
- US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.
Product description
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
Code information (models, lots, serial numbers)
Part #: 90-300-251008 UDI-DI 00849777012478 Lot #(s): 385486-RP25-0080 387070-RP25-0081 415971-RP25-0077 436563-RP25-0082 436564-RP25-0079 436565-RP25-0076 444927-RP25-0078 Part #: 90-300-25508 UDI-DI 00849777012492 Lot #(s): 387071-RP25-0083 418098-RP25-0084 436199-RP25-0085 Part #: 90-300-251004 UDI-DI 00849777012461 Lot #(s): 401347-RP25-0070 415871-RP25-0073 415872-RP25-0074 416678-RP25-0072 416679-RP25-0071 418509-RP25-0075 Part #: 90-400-25508 UDI-DI 00849777012539 Lot #(s): 445442-RP25-0128
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- nanOss 3D Advanced Bone Graft Substitute 90-300-251004Xtant Medical Holdings, Inc. · Filler, Bone Void, Calcium Compound1 recall0 reports
- nanOss 3D Advanced Bone Graft Substitute 90-300-251008Xtant Medical Holdings, Inc. · Filler, Bone Void, Calcium Compound1 recall0 reports
- nanOss 3D Advanced Bone Graft Substitute 90-300-25508Xtant Medical Holdings, Inc. · Filler, Bone Void, Calcium Compound1 recall0 reports
- nanOss 3D Plus Advanced Bone Graft Substitute 90-400-25508Xtant Medical Holdings, Inc. · Filler, Bone Void, Calcium Compound1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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