FDAClass IIMarch 12, 2025

Osstem Implant System - Abutment: ET Multi recall

Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for…

Why was Osstem Implant System - Abutment: ET Multi 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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: UDI-DI: 00810019241543 Lot# H4E22B111

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…
Recalling firm
Hiossen Inc.
Quantity
119 units
Distribution
US Nationwide distribution.
Recall date
March 12, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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