Z-1276-2025 Class II Ongoing
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
- 119 units
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
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: 00810019241543 Lot# H4E22B111