FDAFDA · Food and drugs·Recall number Z-1274-2025
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
Published March 12, 2025 · Recall initiated: January 27, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hiossen Inc.
- Distributor
- US Nationwide distribution.
- Lot
- Lot Code: UDI-DI: 00810019241529 Lot# H4E21D092
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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