Hiossen Dental Abutments Misidentified on Patient Chart Stickers
Hiossen is recalling patient chart stickers for dental abutments that incorrectly identify product versions. Stickers mislabel ET Rigid Abutments as Regular and ET Multi Abutments as Mini. Dentists should verify actual product versions against packaging labels.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II labeling error with no reported illnesses or injuries. The issue is sticker misidentification; actual product packaging and UDI information are correct. Hazard is clinical confusion rather than an inherent product defect.
Plain-English summary
Hiossen Inc. is recalling patient chart stickers supplied with Osstem Implant System Abutments (Model ETMTA503RV1, Lot# H4E21D092, UDI-DI: 00810019241529). The stickers incorrectly identify the abutment versions inside the packaging.
The stickers label ET Rigid Abutments as the Regular version when they are actually Mini version. Similarly, ET Multi Abutments are labeled as Mini version when they are actually Regular version. This misidentification could cause confusion regarding device specifications and selection.
The recall affects 19 units with nationwide distribution in the United States. Dentists and dental professionals should verify the actual abutment version by checking the device packaging, UDI information, and manufacturer specifications rather than relying solely on the included stickers. Contact Hiossen Inc. for guidance on affected units.
The recalled product
- Product
- 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
- Manufacturer
- Hiossen Inc.
- Hazard
- product-misidentification
- labeling-error
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: 00810019241529 Lot# H4E21D092
Distribution
Distributed nationwide across the United States.
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