Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implan
Summary
The FDA issued a Class II for Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment by Hiossen Inc.. Reason: Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mi.
Details
Source
Device Recall
External ID
Z-1274-2025
Action Date
2025-03-12
Status
Ongoing
Category
device
Product Description
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
Lot/Code Info: Lot Code: UDI-DI: 00810019241529 Lot# H4E21D092
Quantity Affected: 19 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-27
Company
Fairless Hills, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 132 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hiossen Inc. has 13 FDA actions in our database, including 7 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hiossen Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hiossen Inc. have FDA actions?
Hiossen Inc. has 13 FDA actions in our database, including 7 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1274-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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