Dental Abutments Recalled for Incorrect Version Identification Stickers
Hiossen Inc. is recalling ET Rigid Abutments due to incorrect patient chart stickers that misidentify product versions. The stickers may label Mini abutments as Regular or identify other abutment models incorrectly, risking use of the wrong component.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 a labeling error in patient chart stickers. No illnesses, injuries, or hospitalizations have been reported. While incorrect product identification could affect clinical outcomes, the actual products are manufactured correctly, and the sticker error can be mitigated by reviewing package documentation.
Plain-English summary
Hiossen Inc. is recalling ET Rigid Abutment (Mini) dental implant abutments distributed nationwide in the US. These abutments are components used with dental implants to provide support for prosthetic restorations such as crowns, bridges, and overdentures.
The recall is due to incorrect patient chart stickers included in the product packaging. The stickers may incorrectly identify the ET Rigid Abutments as the Regular version when they are actually the Mini version. Additionally, the stickers may incorrectly identify ET Multi Abutments as the Mini version when they are actually the Regular version. Using the wrong product version could affect the fit and clinical success of dental restorations.
Dental professionals and patients with this recalled product should verify actual product specifications before use. Check the product itself and package documentation rather than relying on the stickers for identification. Contact Hiossen Inc. with questions about proper product identification.
The recalled product
- Product
- ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4544MP
- Manufacturer
- Hiossen Inc.
- Affected units
- 16
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: 00814913026336 Lot# H4E20L090
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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