CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report

nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus recalled

Xtant Medical Holdings is recalling nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute, distributed nationwide in the US. The recall was initiated on 9 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart #: 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

Quantity recalled225

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1897-2026
FDA event ID: 98643
Recalling firm: Xtant Medical Holdings, Belgrade, MT
Classification: Class II
Status: Ongoing
Recall initiated: 9 Mar 2026
FDA classified: 21 Apr 2026
Reported: 29 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

9 Mar 2026	Recall initiated by company
21 Apr 2026	Classified by FDA	+43 days
29 Apr 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide California Connecticut District of Columbia Kansas Maryland North Carolina New York Texas Wisconsin

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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