Osstem dental implant abutments mislabeled on patient chart stickers
Hiossen is recalling 119 Osstem dental implant abutments because patient chart stickers incorrectly identify product versions. ET Rigid and ET Multi abutments are labeled backwards, potentially leading to selection of the wrong abutment size.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall where patient chart stickers incorrectly identify abutment versions, creating a risk of wrong implant size selection. The mislabeling poses a risk of harm to proper clinical outcomes, with no illnesses or injuries reported to date.
Plain-English summary
Hiossen Inc. is recalling 119 units of Osstem Implant System abutments (Model ETMTA505RV1) due to mislabeled patient chart stickers in the product packaging. The stickers contain incorrect version identification.
Specifically, ET Rigid Abutments are labeled as Regular version when they are actually Mini version, and ET Multi Abutments are labeled as Mini version when they are actually Regular version. This mislabeling could cause healthcare providers to select the wrong abutment size.
Osstem Implant System abutments are used with dental implants to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Selecting an incorrectly sized abutment could result in improper fit and compromised support for the prosthetic restoration.
The affected products (Lot Code: UDI-DI 00810019241543, Lot# H4E22B111) were distributed nationwide in the United States. If you have received these abutments, do not rely on the patient chart stickers for version identification. Contact Hiossen Inc. or your distributor for guidance on how to proceed.
The recalled product
- 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
- Manufacturer
- Hiossen Inc.
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: UDI-DI: 00810019241543 Lot# H4E22B111
Distribution
Distributed nationwide across the United States.
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