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U.S. Department of Health and Human Services

Class 2 Device Recall nanOss 3D

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 Class 2 Device Recall nanOss 3Dsee related information
Date Initiated by FirmMarch 09, 2026
Date PostedApril 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1897-2026
Recall Event ID 98643
510(K)NumberK132050 
Product Classification Filler, bone void, calcium compound - Product Code MQV
ProductnanOss 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 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
FEI Number 3005031160
Recalling Firm/
Manufacturer		 XTANT Medical Holdings, Inc
664 Cruiser Ln
Belgrade MT 59714-9719
For Additional Information ContactMichele Dolan
937-847-8400
Manufacturer Reason
for Recall		Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
FDA Determined
Cause 2		Incorrect or no expiration date
ActionOn 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 Commerce225
DistributionUS Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MQV
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