FDA Enforcement
Class II
Ongoing
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4544MP
Recall: Z-1273-2025
·
Reported March 12, 2025
Enforcement
- Recall Number
- Z-1273-2025
- Event ID
- 96178
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Hiossen Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 12, 2025
- Initiation Date
- January 27, 2025
- Classification Date
- March 5, 2025
- Address
- 85 Ben Fairless Dr, Fairless Hills, PA, 19030-5012, United States
Description
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4544MP
Reason
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
Code Info
Lot Code: UDI-DI: 00814913026336 Lot# H4E20L090
Distribution
US Nationwide distribution.
Quantity
16 units