Z-1604-2023 Class II Ongoing
FDA device recall Z-1604-2023 was initiated by Hiossen Inc. on Apr 6, 2023 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 287 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- Apr 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 287 units
Product Description
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 Pattern
US Nationwide Distribution
Code Information
UDI-DI: 00814913023717 Lot Number: H1E22J263
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1604-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026