Z-1271-2025 Class II Ongoing

Recalled by Hiossen Inc. — Fairless Hills, PA

Recall Details

Product Type
Devices
Report Date
March 12, 2025
Initiation Date
January 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48

Product Description

ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catalog Number: ETRGA4515MP

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 Pattern

US Nationwide distribution.

Code Information

UDI-DI: 00814913026350 Lot# H4E20K117