Hiossen Inc.: Device Recall
Recall #Z-1276-2025 · 01/27/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1276-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Hiossen Inc.
- Status
- Ongoing
- Date Initiated
- 01/27/2025
- Location
- Fairless Hills, PA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 119 units
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
Product Description
Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA505RV1
Distribution Pattern
US Nationwide distribution.
Other Recalls by Hiossen Inc.
- Class II: Risk 01/27/2025
- Class II: Risk 01/27/2025
- Class II: Risk 01/27/2025
- Class II: Risk 01/27/2025
- Class II: Risk 01/27/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.