Reported Mar 12, 2025 · Ongoing
Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental…
Hiossen Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hiossen Inc. · 85 Ben Fairless Dr · Fairless Hills, PA · 19030-5012
Is this the product you have?
- Osstem Implant System - AbutmentET
- Multi AbutmentSize4.8D 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 NumberETMTA505RV1
- Lot codes and dates
- Lot CodeUDI-DI: 00810019241543 Lot# H4E22B111
- Amount recalled
- 119 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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