Z-1897-2026Class II

nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss...

Name: Z-1897-2026 nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss...
Creator: XTANT Medical Holdings, Inc
Published: 2026-03-09
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2026-03-09 / Open, Classified / root cause: labeling and UDI

FDA source

XTANT Medical Holdings, Inc began a recall of nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm... on 2026-03-09. FDA classified it as Class II and gives the reason as "Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1897-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-09
Posted: 2026-04-21
Recalling firm: Xtant Medical Holdings, Inc.
Product: 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
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: 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.
Quantity in commerce: 225
Distribution: US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1897-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1897-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-29	2026-04-21

Product code MQV

K132050Class IINb3d Bone Void FillerPioneer Surgical Technology, Inc. / cleared 2014-02-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)