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Millennium

Avalign Technologies, Inc. · Model 92-F2504 · UDI-DI 00190776398101

HNR
10
510(k) clearances
904
Adverse events
16
Recalls
282
Facilities

Description

Rosenwasser DSEK Donor Lamella Inserting Forceps, 2mm thin semi-pointed tips, angled/vaulted shafts, 12mm from bend to tip, 150 micron (.15mm) gap when tips close, three hole flat handle, 102mm OL, stainless steel

Recalls

DateFirmReason
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField Safety Corrective Action for IFU in DEX Forceps and Scissors.
2026-03-25Katalyst Surgical, LLCField 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.