Class II U.S. Food and Drug Administration

XTANT Medical Holdings, Inc nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus recall: Products were incorrectly labeled with a 5-year shelf life. The approved

Recall published 6 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1897-2026
Published
April 29, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
XTANT Medical Holdings, Inc
Product type
Medical devices
Units affected
225
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
00849777012478, 00849777012492, 00849777012461, 00849777012539

Products covered by this recall

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

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00849777012478
  • 00849777012492
  • 00849777012461
  • 00849777012539

Model or item number

On the rating label, the box or the instruction sheet.

  • 90-300-251008 UDI-DI 00849777012478 Lot
  • 90-300-25508 UDI-DI 00849777012492 Lot
  • 90-300-251004 UDI-DI 00849777012461 Lot
  • 90-400-25508 UDI-DI 00849777012539 Lot

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

XTANT Medical Holdings, Inc — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: XTANT Medical Holdings, Inc — 664 Cruiser Ln, Belgrade, MT, 59714-9719

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was XTANT Medical Holdings, Inc medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00849777012478, 00849777012492, 00849777012461; model number 90-300-251008 UDI-DI 00849777012478 Lot, 90-300-25508 UDI-DI 00849777012492 Lot, 90-300-251004 UDI-DI 00849777012461 Lot. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls