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Rotium

NANOFIBER SOLUTIONS, INC. · Model FG-0430 · UDI-DI 00852513007461

OWW
10
510(k) clearances
3
Adverse events
3
Recalls
16
Facilities

Recalls

DateFirmReason
2026-02-06International Life SciencesAugmentation devices failed bacterial endotoxin testing.
2026-02-06International Life SciencesAugmentation devices failed bacterial endotoxin testing.
2026-02-06International Life SciencesAugmentation devices failed bacterial endotoxin testing.

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Data 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.