Recall Z-1897-2026 ยท MQV Filler, Bone Void, Calcium Compound
XTANT Medical Holdings, Inc
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
| Date | Apr 21, 2026 (initiated Mar 9, 2026) |
| Status | Open, Classified |
| Reason | Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years. |
| 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 | 225 |
| Distribution | US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132050 | NB3D BONE VOID FILLER Pioneer Surgical Technology, Inc., Feb 7, 2014 |