Class II Recall: nanOss 3D Bone Graft by XTANT Medical - Incorrect Shelf Life Labeling

Class 2 Device Recall nanOss 3D

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| | Class 2 Device Recall nanOss 3D | |

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 Contact | Michele 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 | 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. |
| Total Product Life Cycle | TPLC 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) Database | 510(K)s with Product Code = MQV |