Hiossen Inc.: 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, bri

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

Details from the source

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. Quantity: 119 units Lot/code info: Lot Code: UDI-DI: 00810019241543 Lot# H4E22B111

UPC codes

00810019241543

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.