FDA Device recall Z-1604-2023
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
- FDA Device
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B by Hiossen, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1604-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-06 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hiossen |
| Distribution | US |
Product
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Reason
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
Identifiers
| code_info | UDI-DI: 00814913023717 Lot Number: H1E22J263 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1604-2023%22
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