ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B… — Class II medical device recall Z-1604-2023
Ongoing recall by Hiossen Inc., reported 2023-05-24, distributed nationwide. Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, l
| Recall number | Z-1604-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hiossen Inc., Fairless Hills, PA, United States |
| Recall initiated | 2023-04-06 |
| Classified | 2023-05-18 |
| Reported by FDA | 2023-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 287 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00814913023717 |
| Lot numbers | H1E22J263 |
| Model numbers | AET3R5010B, ET3R5010B |
Product
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Reason for recall
Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1604-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.