XTANT Medical Holdings, Inc recalls nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute…
Reason for recall
Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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, 10ccUDI-DI 0084977701247823 affected lots385486-RP25-0080387070-RP25-0081415971-RP25-0077436563-RP25-0082436564-RP25-0079436565-RP25-0076444927-RP25-007890-300-25508
+15 more
00849777012492387071-RP25-0083418098-RP25-0084436199-RP25-008590-300-25100400849777012461401347-RP25-0070415871-RP25-0073415872-RP25-0074416678-RP25-0072416679-RP25-0071418509-RP25-007590-400-2550800849777012539445442-RP25-0128
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1897-2026
- FDA 510(k) clearance · K132050The device's official FDA premarket clearance record
- FDA device classification · MQVOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3045The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find XTANT Medical Holdings, IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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