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FDA (Device enforcement)Recalled 2025-01-27class ii

Hiossen Inc.: ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Cat

Hazard

Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version

Details from the source

Reason for recall: Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version Distribution: US Nationwide distribution. Quantity: 19 units Lot/code info: Lot Code: UDI-DI: 00814913026312 Lot# H4E21G062

UPC codes

00814913026312

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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