Dental implant system recalled for incorrect package length labeling
Hiossen Inc. is recalling 287 units of ET III Nano-HA dental implants due to incorrect package labeling stating implant length as 10mm when the actual length is 8.5mm. No illnesses or injuries have been reported.
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 medical device recall involving a labeling error. The package mislabels the implant length as 10mm when the actual dimension is 8.5mm. No illnesses, injuries, or adverse events have been reported, and the hazard is a documentation discrepancy rather than a defect in the implant itself.
Plain-English summary
Hiossen Inc. is recalling 287 units of the ET III Nano-HA Dental Implant (Model # ET3R5010B) due to a labeling discrepancy on the product package. The implants are labeled as having dimensions of D5.0 x L10mm, but the actual implant dimensions are D5.0 x L8.5mm.
The mislabeling could lead to incorrect surgical planning if a dentist or surgeon relies on the package labeling rather than verifying the actual implant dimensions before use. The recalled product was distributed nationwide in the United States.
Patients or dentists who possess this product should verify the actual implant dimensions independently and not rely on the package label for surgical specifications. The affected lot is H1E22J263 (UDI-DI: 00814913023717). No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
- Manufacturer
- Hiossen Inc.
- Hazard
- mislabeling
- dimension-mismatch
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: 00814913023717 Lot Number: H1E22J263
Distribution
Distributed nationwide across the United States.
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