Dental abutment implants recalled for incorrect patient chart stickers
Hiossen Inc. is recalling ET Rigid Abutment (Mini) dental implant components due to patient chart stickers that incorrectly identify the product version. The stickers may identify Mini versions as Regular, or Multi-versions as Mini.
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 on patient identification stickers with no reported patient harm, illnesses, or injuries. The hazard is theoretical—incorrect product identification could lead to improper restoration planning—but no clinical complications have been documented.
Plain-English summary
Hiossen Inc. is recalling ET Rigid Abutment (Mini) dental implant components (Model ETRGA4537MP, UDI-DI: 00814913026428, Lot# H4E20L088) due to mislabeled patient chart stickers included in the product packaging. The stickers incorrectly identify the ET Rigid Abutments as the Regular version when the products are actually Mini versions, and may also incorrectly identify ET Multi Abutments as Mini versions when they are actually Regular versions.
These patient chart stickers are used to document prosthetic restoration information in patient records. Using incorrect product version information could lead to selection of incompatible prosthetic components or improper restoration planning.
The recall affects 19 units distributed nationwide in the United States. Healthcare providers and clinics who received products from this lot should verify the actual product version and correct any patient records that may have been created using the incorrect sticker identification.
The recalled product
- Product
- ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4537MP
- Manufacturer
- Hiossen Inc.
- Hazard
- Affected units
- 19
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: 00814913026428 Lot# H4E20L088
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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