Dental implant abutments recalled for incorrect packaging labels
Hiossen has recalled ET Rigid Abutment dental implant components because stickers in the packaging mislabel whether products are Mini or Regular versions. Incorrect identification could affect proper implant installation.
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: This is an FDA Class II recall involving packaging labeling errors with no reported injuries or illnesses. The hazard is product misidentification, representing a risk of improper clinical use, which meets the criteria for Moderate severity per the rubric.
Plain-English summary
Hiossen Inc. is recalling ET Rigid Abutment (Mini) dental implant components due to labeling errors on patient chart stickers included in the product packaging. The affected product lot includes 48 units distributed nationwide.
The issue is that stickers in the packaging incorrectly identify ET Rigid Abutments as Regular version when they are actually Mini version, and incorrectly identify ET Multi Abutments as Mini version when they are actually Regular version. This labeling confusion could lead to incorrect product identification and improper installation during dental implant procedures.
Dental professionals who received this product should independently verify the actual product version before clinical use. If you have received product with lot number H4E20K117 and UDI-DI 00814913026350, contact Hiossen Inc. for replacement or guidance. No injuries or illnesses have been reported related to this labeling error.
The recalled product
- Product
- ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catalog Number: ETRGA4515MP
- Manufacturer
- Hiossen Inc.
- Affected units
- 48
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)
- UDI-DI: 00814913026350 Lot# H4E20K117
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Hiossen Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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