ModerateClass IIOngoing

FDA Devices recall · Reported April 29, 2026

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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on April 29, 2026. Severity: Moderate. Recall number: Z-1897-2026.

Q: Where was the recalled product distributed?

Distribution: US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1897-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

Recall #: Z-1897-2026
Affected scope: 225
Initiated: March 9, 2026

Compiled from official public sources by the editorial team. · Updated July 2026

Verify with FDA Devices →

View my saved recalls

Xtant Medical Holdings, Inc recalled nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute … - a moderate-severity action.

nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute … was recalled by Xtant Medical Holdings, Inc in April 29, 2026. Reason: Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four yea…. Check the official notice for the remedy. Verify recall #Z-1897-2026 with the FDA Devices before acting.

Share: Post Facebook LinkedIn WhatsApp Email

The recall

Xtant Medical Holdings, Inc issued this moderate-severity FDA Devices recall-Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four yea….

Moderate
severity level: 225 units
affected scope: Class II
classification: April 29, 2026
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1897-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1897-2026) was formally reported on April 29, 2026, with the manufacturer initiating the action on March 9, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Xtant Medical Holdings, Inc is listed as the recalling firm, operating out of Belgrade, MT. Federal records list the affected scope as 225.

The documented reason for this recall is: Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

225

Related Recalls

3 from same agency

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

Reason for recall

Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-1897-2026
Date reported	April 29, 2026
Date initiated	March 9, 2026
Recalling firm	Xtant Medical Holdings, Inc
Firm location	Belgrade, MT
Affected scope	225
Distribution	US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

225 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1897-2026) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 29, 2026. Severity: Moderate. Recall number: Z-1897-2026.

Where was the recalled product distributed? ▼

Distribution: US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1897-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

CPSC Moderate

Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards

· 2026-07-02

CPSC Moderate

Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…

· 2026-06-25

CPSC Moderate

Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…

· 2026-06-18

FDA Devices Moderate

GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…

GE Medical Systems Information Technologies Inc · 2026-06-03

FDA Devices Critical

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…

Medline Industries, LP · 2026-06-03

Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →

Browse all Medical Devices recalls →

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 29, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.