FDA action counts
| Total FDA actions | 2 |
|---|---|
| Warning letters | 0 |
| Recalls | 2 |
| Approval records | 0 |
| Form 483 inspection citations | 0 |
| Most recent action | April 29, 2026 |
Enforcement history
On 2026-04-15, Argus HQ recorded a FDA recall for XTANT Medical Holdings, Inc, rated "high" severity in Argus HQ's classification: XTANT Medical Holdings, Inc — Class II recall: XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X07… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for XTANT Medical Holdings, Inc, rated "high" severity in Argus HQ's classification: XTANT Medical Holdings, Inc — Class II recall: nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Sub… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, XTANT Medical Holdings, Inc has 2 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.
Risk pattern analysis
Argus HQ analysis — not an FDA finding
This section is Argus HQ analysis, not an FDA finding. XTANT Medical Holdings, Inc has 2 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.
Frequently asked questions
- How many FDA actions has XTANT Medical Holdings, Inc had?
- Argus HQ has recorded 2 FDA events for XTANT Medical Holdings, Inc: 0 warning letters, 2 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
- What is the most recent FDA action against XTANT Medical Holdings, Inc?
- The most recent FDA event Argus HQ has on file for XTANT Medical Holdings, Inc is dated 2026-04-29, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
- Does Argus HQ track new FDA actions for XTANT Medical Holdings, Inc automatically?
- Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to XTANT Medical Holdings, Inc is observed, this page's event count and history update automatically.
- How many FDA actions does Argus HQ track for XTANT Medical Holdings, Inc?
- 2 total: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.
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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Enforcement History: XTANT Medical Holdings, Inc. Digital Empire LLC. Retrieved from https://argushq.ai/company/xtant-medical-holdings-inc
"FDA Enforcement History: XTANT Medical Holdings, Inc." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/xtant-medical-holdings-inc.
Argus HQ Research. "FDA Enforcement History: XTANT Medical Holdings, Inc." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/xtant-medical-holdings-inc.
@misc{argushq_argushq_ai_company_xtant_medical_holdings_inc_2026,
title = {FDA Enforcement History: XTANT Medical Holdings, Inc},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/company/xtant-medical-holdings-inc},
note = {Accessed: July 13, 2026}
}Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗