FDA recall Z-1276-2025

Product

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

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2025-01-27

Report date

2025-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairless Hills, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1276-2025