Z-1274-2025 Class II Ongoing
FDA device recall Z-1274-2025 was initiated by Hiossen Inc. on Jan 27, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 19 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 12, 2025
- Initiation Date
- Jan 27, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
Product Description
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
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
Lot Code: UDI-DI: 00810019241529 Lot# H4E21D092
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1274-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026