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Rumex

RUMEX INTERNATIONAL CORP. · Model 4-2144T · UDI-DI 00840159906330

HNR

510(k) clearances

888

Adverse events

Recalls

279

Facilities

Description

Forceps for ICRS Implantation, With 1x1 Teeth, 0.30mm Groove, Length 85 mm, Flat Handle, Titanium

Recalls

Date	Firm	Reason
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25	Katalyst Surgical, LLC	Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding
2026-03-25	Katalyst Surgical, LLC	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

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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.