# FDA recall Z-1604-2023

> **Hiossen Inc.** · Class II · device recall initiated 2023-04-06.

## 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

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1604-2023
- **Recalling firm:** Hiossen Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-06
- **Report date:** 2023-05-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fairless Hills, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1604-2023

## Citation

> AI Analytics. FDA recall Z-1604-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1604-2023. Source: US FDA. Licensed CC0.

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