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Xenix Medical Sacroiliac Fixation System
XENIX MEDICAL LLC · Model UN1-A4-020010 · UDI-DI 00818345028173
1
510(k) clearances
1,408
Adverse events (5 deaths)
1
Recalls
159
Facilities
Description
1/4" Sq to Tri-Flat Adapter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.